{ "code": "LIT", "deviceName": "Catheter, Angioplasty, Peripheral, Transluminal", "deviceClass": "II", "regulationNumber": "870.1250", "panel": "Cardiovascular", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 403, "last12Months": 3 }, "adverseEvents": { "total": 5856, "last12Months": 1405 }, "reviewDays": { "median": 87, "sampleSize": 403 }, "recalls": { "total": 32, "recent": [ { "resNumber": "Z-1042-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.", "initiated": "2025-12-03" }, { "resNumber": "Z-1704-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "SUMMA THERAPEUTICS, LLC", "firmAsPublished": "SUMMA THERAPEUTICS, LLC", "reason": "Potential for the balloon in the device to not meet burst specifications.", "initiated": "2025-07-21" }, { "resNumber": "Z-0904-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "ev3, Inc.", "firmAsPublished": "ev3 Inc", "reason": "There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.", "initiated": "2024-12-10" }, { "resNumber": "Z-0257-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Covidien", "firmAsPublished": "Covidien LP", "reason": "Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.", "initiated": "2024-09-19" }, { "resNumber": "Z-0557-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "Covidien", "firmAsPublished": "Covidien Llc", "reason": "The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector\nsleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks\nassociated with surgical intervention, or delay to treatment/therapy.", "initiated": "2021-12-17" } ] }, "recentClearances": [ { "kNumber": "K260304", "deviceName": "WAVE PTA Balloon Catheter", "applicant": "WAVE Medical AG", "company": "WAVE Medical AG", "decisionDate": "2026-05-20", "dateReceived": "2026-01-30" }, { "kNumber": "K252512", "deviceName": "Armada™ 14 NC PTA Catheter", "applicant": "ABBOTT MEDICAL", "company": "Abbott Medical", "decisionDate": "2026-02-13", "dateReceived": "2025-08-11" }, { "kNumber": "K251915", "deviceName": "Amethyst HP PTA OTW 0.035 Catheter", "applicant": "Natec Medical , Ltd.", "company": "Natec Medical , Ltd.", "decisionDate": "2025-12-18", "dateReceived": "2025-06-23" }, { "kNumber": "K250706", "deviceName": "Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter", "applicant": "Biotronik, Inc.", "company": "BIOTRONIK, Inc.", "decisionDate": "2025-04-04", "dateReceived": "2025-03-10" }, { "kNumber": "K243704", "deviceName": "Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter", "applicant": "Brosmed Medical Co., Ltd.", "company": "BrosMed Medical Co.,Ltd.", "decisionDate": "2025-02-27", "dateReceived": "2024-11-29" }, { "kNumber": "K241040", "deviceName": "Amethyst HP PTA OTW 0.035 Catheter", "applicant": "Natec Medical , Ltd.", "company": "Natec Medical , Ltd.", "decisionDate": "2024-12-18", "dateReceived": "2024-04-16" }, { "kNumber": "K242419", "deviceName": "018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter", "applicant": "Creagh Medical Ltd. Dba Surmodics, Inc.", "company": "Creagh Medical Ltd. Dba Surmodics, Inc.", "decisionDate": "2024-11-15", "dateReceived": "2024-08-15" }, { "kNumber": "K241740", "deviceName": "Finesse Injectable™ PTA Balloon Dilatation Catheter", "applicant": "Summa Therapeutics", "company": "SUMMA THERAPEUTICS, LLC", "decisionDate": "2024-07-16", "dateReceived": "2024-06-17" }, { "kNumber": "K241711", "deviceName": "Oscar Peripheral Multifunctional Catheter system", "applicant": "Biotronik, Inc.", "company": "BIOTRONIK, Inc.", "decisionDate": "2024-07-11", "dateReceived": "2024-06-14" }, { "kNumber": "K241683", "deviceName": "Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314", "applicant": "Boston Scientific Corporation", "company": "Boston Scientific Corporation", "decisionDate": "2024-07-10", "dateReceived": "2024-06-11" } ], "topApplicants": [ { "name": "Boston Scientific Corp", "count": 38 }, { "name": "Cordis Corp.", "count": 25 }, { "name": "Meadox Medicals, Div. Boston Scientific Corp.", "count": 14 }, { "name": "Vas-Cath, Inc.", "count": 14 }, { "name": "C.R. Bard, Inc.", "count": 13 } ], "topCompanies": [ { "name": "Boston Scientific Corporation", "count": 52, "spellings": 3 }, { "name": "Cordis Corporation", "count": 30, "spellings": 2 }, { "name": "Meadox Medicals, Div. Boston Scientific Corp.", "count": 14, "spellings": 1 }, { "name": "Vas-Cath, Inc.", "count": 14, "spellings": 1 }, { "name": "C.R. Bard, Inc.", "count": 13, "spellings": 1 } ], "newEntrants": [ { "name": "WAVE Medical AG", "since": "2026-05-20", "kNumber": "K260304" }, { "name": "Abbott Medical", "since": "2026-02-13", "kNumber": "K252512" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 173, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 181, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 201, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 171, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 135, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 144, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 126, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 110, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 129, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 125, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 154, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 138, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 173, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 187, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 120, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 197, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 165, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 157, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 202, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 126, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 169, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 122, "expectedLow": 103.76833951635916, "expectedHigh": 189.98935396313115, "isSufficient": true }, { "month": "2025-02-01", "observed": 136, "expectedLow": 84.48776698607905, "expectedHigh": 159.11442769775292, "isSufficient": true }, { "month": "2025-03-01", "observed": 133, "expectedLow": 99.00661932296462, "expectedHigh": 182.78659091142617, "isSufficient": true }, { "month": "2025-04-01", "observed": 179, "expectedLow": 100.04342841609031, "expectedHigh": 187.32944688985734, "isSufficient": true }, { "month": "2025-05-01", "observed": 154, "expectedLow": 103.53508441572814, "expectedHigh": 185.82058535116178, "isSufficient": true }, { "month": "2025-06-01", "observed": 160, "expectedLow": 111.60205318671596, "expectedHigh": 192.8436767011078, "isSufficient": true }, { "month": "2025-07-01", "observed": 193, "expectedLow": 183.00857916454956, "expectedHigh": 305.0097079445899, "isSufficient": true }, { "month": "2025-08-01", "observed": 160, "expectedLow": 125.78755576259795, "expectedHigh": 219.05376356063016, "isSufficient": true }, { "month": "2025-09-01", "observed": 222, "expectedLow": 127.86033268168468, "expectedHigh": 227.1569832110962, "isSufficient": true }, { "month": "2025-10-01", "observed": 182, "expectedLow": 135.38343797624717, "expectedHigh": 244.79034927704433, "isSufficient": true }, { "month": "2025-11-01", "observed": 200, "expectedLow": 121.72710649653776, "expectedHigh": 214.77094207737065, "isSufficient": true }, { "month": "2025-12-01", "observed": 183, "expectedLow": 147.13525245807134, "expectedHigh": 248.02851117965065, "isSufficient": true }, { "month": "2026-01-01", "observed": 160, "expectedLow": 164.1379039364378, "expectedHigh": 280.5829923770022, "isSufficient": true }, { "month": "2026-02-01", "observed": 151, "expectedLow": 120.76842335647963, "expectedHigh": 224.90090795890677, "isSufficient": true }, { "month": "2026-03-01", "observed": 193, "expectedLow": 121.78332659332224, "expectedHigh": 242.1044747399451, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "LIT (Catheter, Angioplasty, Peripheral, Transluminal) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1042-2026). 2 first-time filers in the last 12 months, WAVE Medical AG and Abbott Medical (K260304, K252512). The code is crowded, scoring 74 of 100 — 103 companies hold a clearance here and 3 arrived in the last 12 months (LIT:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-1042-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, WAVE Medical AG and Abbott Medical", "recordIds": [ "K260304", "K252512" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 74 of 100 — 103 companies hold a clearance here and 3 arrived in the last 12 months", "recordIds": [ "LIT:crowding" ], "severity": 20 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3ALIT" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALIT" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALIT" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALIT" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALIT" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALIT" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALIT" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.738Z" }