Medical device manufacturer
Medtronic Vascular
Medtronic Vascular holds 480 FDA 510(k) clearances across 83 product codes. Median elapsed review time is 74 days. openFDA lists 234 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 480
- Product codes
- 83
- Median review
- 74 days
- Recall records
- 234
How does FDA spell Medtronic Vascular?
FDA publishes this company under 8 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| MEDTRONIC VASCULAR | device/registrationlisting | normalised |
| Medtronic Vascular | device/enforcement | normalised |
| Medtronic Vascular | device/registrationlisting | normalised |
| Medtronic Vascular | device/510k | normalised |
| Medtronic Vascular | device/recall | normalised |
| Medtronic Vascular, Inc. | device/510k | normalised |
| Medtronic Vascular, Inc. | device/recall | normalised |
| Medtronic Vascular, Inc. | device/enforcement | normalised |
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Medtronic Vascular file in?
83 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 69 | 87 days | |
| DXY | Implantable Pacemaker Pulse-Generator | 59 | 76 days | |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 56 | 96 days | |
| DQY | Catheter, Percutaneous | 31 | 44 days | |
| LDF | Electrode, Pacemaker, Temporary | 21 | 69 days | |
| DTD | Pacemaker Lead Adaptor | 19 | 64 days | |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 15 | 37 days | |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 12 | 99 days | |
| GXY | Electrode, Cutaneous | 10 | 35 days | |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 10 | 26 days | |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 8 | 89 days | |
| DYB | Introducer, Catheter | 7 | 111 days | |
| DRX | Electrode, Electrocardiograph | 6 | 65 days | |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 6 | 29 days | |
| DQX | Wire, Guide, Catheter | 5 | 76 days | |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 5 | 56 days | |
| DTC | Analyzer, Pacemaker Generator Function | 5 | 88 days | |
| DTE | Pulse-Generator, Pacemaker, External | 5 | 40 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 5 | 129 days | |
| IPF | Stimulator, Muscle, Powered | 5 | 36 days | |
| IYX | Camera, Scintillation (Gamma) | 5 | 28 days | |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 4 | 83 days | |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 | 17 days | |
| DTP | Defoamer, Cardiopulmonary Bypass | 4 | 86 days | |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 4 | 69 days |
Showing the 25 they file in most, of 83.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Medtronic Vascular had a recall?
openFDA lists 234 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1042-2022Class IIOpen, ClassifiedONU
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Z-1043-2022Class IIOpen, ClassifiedPRC
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Z-0657-2022Class IIOpen, ClassifiedMIH
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Z-0290-2022Class IIOpen, ClassifiedMIH
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Z-0291-2022Class IIOpen, ClassifiedMIH
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Showing the 5 most recently initiated of 234.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Medtronic Vascular cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K232570 | Steerant Super Stiff Guidewire | DQX | 61 | |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | DQY | 29 | |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | DQY | 162 | |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) | MAV | 28 | |
| K192296 | Medtronic 6F Taiga Guiding Catheter | DQY | 28 | |
| K182957 | Heli-FX EndoAnchor System | OTD | 28 | |
| K173515 | Admiral Xtreme | LIT | 149 | |
| K171866 | Sentrant Introducer Sheath with Hydrophilic Coating | DYB | 181 | |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System | MCW | 144 | |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | OTD | 29 |
Source: openFDA device/510k · retrieved
Where is Medtronic Vascular registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Medtronic Vascular files next
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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.