Medtronics Interventional Vascular: FDA clearances and approvals
Medtronics Interventional Vascular has 21 FDA 510(k) clearances (first 1992, latest 1999), plus 2 PMA decisions, across 8 product codes in 1 review panel. Median 510(k) review time: 161 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 11 | 11 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| MAV | Syringe, Balloon Inflation | 2 | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 0 |
| MAF | Stent, Coronary | 1 | 0 |
Review panels
- Cardiovascular (23)
Most recent Medtronics Interventional Vascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990707 | MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS | DQY | 1999-03-22 | 18 |
| K980973 | MEDTRONIC ANGIOGRAPHIC CATHETER | DQO | 1998-12-10 | 269 |
| K982883 | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | DQY | 1998-09-04 | 18 |
| K981198 | MEDTRONIC ZUMA GUIDING CATHETER | DQY | 1998-08-07 | 127 |
| K972944 | MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT | DQX | 1997-11-03 | 84 |
| K961917 | MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) | DQX | 1996-11-20 | 187 |
| K960983 | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | MAV | 1996-05-30 | 80 |
| K955651 | MEDTRONIC SHERPA GUIDING CATHETER | DQY | 1996-01-22 | 41 |
| K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER | DQY | 1995-11-21 | 288 |
| K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER | DQY | 1995-07-25 | 189 |
11 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960010 | PMA | MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM | 1997-06-27 |
| P870036 | PMA | VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM | 1988-03-25 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronics Interventional Vascular.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medtronics Interventional Vascular's product codes (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances does Medtronics Interventional Vascular have?
Medtronics Interventional Vascular has 21 FDA 510(k) clearances (first 1992, latest 1999), plus 2 PMA decisions, across 8 product codes in 1 review panel.
How long does FDA take to clear Medtronics Interventional Vascular's 510(k)s?
The median time from FDA receipt to decision across Medtronics Interventional Vascular's cleared 510(k)s is 161 days.
What devices does Medtronics Interventional Vascular make?
Its most frequent FDA product codes are DQY (Catheter, Percutaneous, 11); DQX (Wire, Guide, Catheter, 3); DQO (Catheter, Intravascular, Diagnostic, 2).
Has Medtronics Interventional Vascular had device recalls?
openFDA lists no recalls under a recalling firm name matching Medtronics Interventional Vascular. Related entities may recall under other names.
Next steps
- See all 21 Medtronics Interventional Vascular clearances with predicates and recalls
- Run predicate analysis for product code DQY, Medtronics Interventional Vascular's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.