Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Heart Valve Div. Medtronic Cardiovascular Surg · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
193 daysmedian FDA review time
280 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980534 | DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998-04-30 | 78 | 0 |
| K960356 | POSTERIOR ANNULOPLASTY BAND (MODEL 607) | The Heart Valve Div. Medtronic Cardiovascular Surg | 1996-08-27 | 215 | 0 |
| K944956 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 | The Heart Valve Div. Medtronic Cardiovascular Surg | 1995-07-14 | 280 | 0 |
| K922269 | UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 | The Heart Valve Div. Medtronic Cardiovascular Surg | 1992-11-23 | 193 | 0 |
| K914602 | DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED | The Heart Valve Div. Medtronic Cardiovascular Surg | 1991-11-22 | 38 | 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