Medtronic Ave, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Medtronic Ave, Inc.” (first 1999, latest 2003), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 56 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 | 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 11 | 11 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
Review panels
Most recent Medtronic Ave, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032768 | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) | FGE | 2003-10-09 | 31 |
| K030633 | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT | FGE | 2003-09-02 | 186 |
| K030839 | MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) | FGE | 2003-05-30 | 74 |
| K022026 | MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) | FGE | 2002-07-19 | 28 |
| K014205 | MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) | FGE | 2002-01-14 | 24 |
| K011080 | BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM | FGE | 2001-10-11 | 185 |
| K011817 | BRIDGE FX | FGE | 2001-08-22 | 72 |
| K002346 | WIRE, GUIDE, CATHETER, MODEL QSW1000 | DQX | 2000-09-27 | 56 |
| K994141 | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 | MJN | 2000-07-21 | 226 |
| K000744 | MEDTRONIC AVE BRIDGE X3 STENT | FGE | 2000-06-05 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-02-27.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (184 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Bio-Medicus, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Ave, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Medtronic Ave, Inc.” (first 1999, latest 2003), across 3 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 Medtronic Ave, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Ave, Inc. is 56 days.
Which FDA product codes appear under Medtronic Ave, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 11); DQX (Wire, Guide, Catheter, 1); MJN (Catheter, Intravascular Occluding, Temporary, 1).
Next steps
- See all 13 Medtronic Ave, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Medtronic Ave, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.