Medtronics Interventional Vascular
Danvers, MA, US
Medtronics Interventional Vascular appears in FDA device records in Danvers, MA. FDA records list 21 510(k) clearances between and , 45 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 45
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Medtronics Interventional Vascular between 1992 and 1999. The busiest year on record is 1994, with 5. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 5 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990707 | MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS | DQY | Substantially Equivalent | |
| K980973 | MEDTRONIC ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K982883 | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | DQY | Substantially Equivalent | |
| K981198 | MEDTRONIC ZUMA GUIDING CATHETER | DQY | Substantially Equivalent | |
| K972944 | MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT | DQX | Substantially Equivalent | |
| K961917 | MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) | DQX | Substantially Equivalent | |
| K960983 | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | MAV | Substantially Equivalent | |
| K955651 | MEDTRONIC SHERPA GUIDING CATHETER | DQY | Substantially Equivalent | |
| K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K950026 | MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K944668 | SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS | DQY | Substantially Equivalent | |
| K945461 | PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) | DTL | Substantially Equivalent | |
| K942269 | MEDTRONIC EVEREST INFLATION DEVICE | MAV | Substantially Equivalent | |
| K935738 | MEDTRONIC GCIII CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K935425 | METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS | DQY | Substantially Equivalent | |
| K940063 | MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS | LIT | Substantially Equivalent | |
| K932933 | GC IV CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K925342 | MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE | DQX | Substantially Equivalent | |
| K923638 | ACESSORY PACK | LIT | Substantially Equivalent | |
| K915351 | SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER | DQO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- LITCatheter, Angioplasty, Peripheral, Transluminal
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- MAFStent, Coronary
- MAVSyringe, Balloon Inflation
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain