Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Ave, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
186 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032768 | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD | Medtronic Ave, Inc. | 2003-10-09 | 31 | 1 |
| K030633 | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONS | Medtronic Ave, Inc. | 2003-09-02 | 186 | 0 |
| K030839 | MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) | Medtronic Ave, Inc. | 2003-05-30 | 74 | 0 |
| K022026 | MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) | Medtronic Ave, Inc. | 2002-07-19 | 28 | 0 |
| K014205 | MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY | Medtronic Ave, Inc. | 2002-01-14 | 24 | 0 |
| K011080 | BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM | Medtronic Ave, Inc. | 2001-10-11 | 185 | 0 |
| K011817 | BRIDGE FX | Medtronic Ave, Inc. | 2001-08-22 | 72 | 0 |
| K002346 | WIRE, GUIDE, CATHETER, MODEL QSW1000 | Medtronic Ave, Inc. | 2000-09-27 | 56 | 0 |
| K994141 | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510 | Medtronic Ave, Inc. | 2000-07-21 | 226 | 0 |
| K000744 | MEDTRONIC AVE BRIDGE X3 STENT | Medtronic Ave, Inc. | 2000-06-05 | 90 | 0 |
| K993145 | MEDTRONIC AVE BRIDGE STENT | Medtronic Ave, Inc. | 1999-10-21 | 31 | 0 |
| K992569 | MEDTRONIC AVE BRIDGE STENT | Medtronic Ave, Inc. | 1999-08-31 | 29 | 0 |
| K992318 | MEDTRONIC AVE BRIDGE STENT | Medtronic Ave, Inc. | 1999-08-02 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda