Ev3, Inc.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Ev3, Inc.” (first 2003, latest 2014), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 52 |
| 2014 | 1 | 79 |
| 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 12 | 12 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 7 | 7 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| MCW | Catheter, Peripheral, Atherectomy | 4 | 4 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 3 | 3 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 3 | 3 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 2 |
Review panels
Most recent Ev3, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER | LIT | 2014-07-18 | 79 |
| K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER | LIT | 2013-09-26 | 21 |
| K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER | LIT | 2013-05-24 | 52 |
| K123544 | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER | LIT | 2013-02-12 | 85 |
| K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | MCW | 2011-10-27 | 129 |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | 2011-10-27 | 199 |
| K111490 | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS | KRA | 2011-09-16 | 108 |
| K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER | LIT | 2011-04-14 | 70 |
| K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | MCW | 2011-01-05 | 26 |
| K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | LIT | 2010-12-06 | 24 |
30 earlier clearances. See the full list in Caduvo.
Recalls
91 product recalls in 34 recall events; 5 initiated in the last five years. Most recent: 2024-12-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ev3, Inc.?
FDA lists 40 510(k) clearances under the applicant name “Ev3, Inc.” (first 2003, latest 2014), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ev3, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ev3, Inc. is 34 days.
Which FDA product codes appear under Ev3, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 12); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 7); DQY (Catheter, Percutaneous, 4).
Next steps
- See all 40 Ev3, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Ev3, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.