FDA product code · Cardiovascular
LITCatheter, Angioplasty, Peripheral, Transluminal
Product code LIT covers Catheter, Angioplasty, Peripheral, Transluminal, a Class II device regulated under 21 CFR 870.1250. FDA has cleared 403 devices in this code, 3 of them in the last 12 months. Median review time across the 403 most recent decisions is 87 days. openFDA lists 32 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1250
- Review panel
- Cardiovascular
- Clearances
- 403
What is happening in LIT right now?
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).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1042-2026 |
| New entrant | Worth knowing | K260304, K252512 |
| Crowding | Context | LIT:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LIT?
FDA has cleared 403 devices under product code LIT since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | |
| K252512 | Armada 14 NC PTA Catheter | ABBOTT MEDICAL | |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | |
| K250706 | 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 | Biotronik, Inc. | |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | |
| K241740 | Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics | |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | |
| K241683 | 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 | Boston Scientific Corporation |
How long does FDA review take for LIT?
The median FDA review time for LIT is 87 days, measured across the 403 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LIT?
openFDA lists 32 recall records against product code LIT. A recall record covers one firm's corrective action and may span many device lots.
Z-1042-2026Open, ClassifiedBoston Scientific Corporation
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.
Z-1704-2026Open, ClassifiedSUMMA THERAPEUTICS, LLC
Potential for the balloon in the device to not meet burst specifications.
Z-0904-2025Open, Classifiedev3, Inc.
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Z-0257-2025Open, ClassifiedCovidien
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Z-0557-2022Open, ClassifiedCovidien
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 sleeve 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 associated with surgical intervention, or delay to treatment/therapy.
Showing the 5 most recently initiated of 32. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LIT?
MAUDE holds 5,856 adverse-event reports naming product code LIT, 1,405 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LIT unusual?
Every month with enough history behind it falls inside LIT's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 173 | Insufficient history | No expected range — too little history | |
| 181 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 171 | Insufficient history | No expected range — too little history | |
| 135 | Insufficient history | No expected range — too little history | |
| 144 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 110 | Insufficient history | No expected range — too little history | |
| 129 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 154 | Insufficient history | No expected range — too little history | |
| 138 | Insufficient history | No expected range — too little history | |
| 173 | Insufficient history | No expected range — too little history | |
| 187 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 197 | Insufficient history | No expected range — too little history | |
| 165 | Insufficient history | No expected range — too little history | |
| 157 | Insufficient history | No expected range — too little history | |
| 202 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 169 | Insufficient history | No expected range — too little history | |
| 122 | 104–190 | Within expected (104–190) | |
| 136 | 84–159 | Within expected (84–159) | |
| 133 | 99–183 | Within expected (99–183) | |
| 179 | 100–187 | Within expected (100–187) | |
| 154 | 104–186 | Within expected (104–186) | |
| 160 | 112–193 | Within expected (112–193) | |
| 193 | 183–305 | Within expected (183–305) | |
| 160 | 126–219 | Within expected (126–219) | |
| 222 | 128–227 | Within expected (128–227) | |
| 182 | 135–245 | Within expected (135–245) | |
| 200 | 122–215 | Within expected (122–215) | |
| 183 | 147–248 | Within expected (147–248) | |
| 160 | 164–281 | Below expected (164–281) | |
| 151 | 121–225 | Within expected (121–225) | |
| 193 | 122–242 | Within expected (122–242) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in LIT.
Who has entered LIT in the last year?
2 companies filed in LIT for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| WAVE Medical AG | K260304 | |
| Abbott Medical | K252512 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in LIT?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LIT?
Across the 403 most recent decisions, these applicants filed most often in LIT.
| Applicant | Recent clearances |
|---|---|
| Boston Scientific Corp | 38 |
| Cordis Corp. | 25 |
| Meadox Medicals, Div. Boston Scientific Corp. | 14 |
| Vas-Cath, Inc. | 14 |
| C.R. Bard, Inc. | 13 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in LIT file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Boston Scientific Corporation | 52 | 3 |
| Cordis Corporation | 30 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch LIT
Get an email the morning anything changes in LIT — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.