Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Cardiac Surgical Products · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
334 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (1 | Medtronic Cardiac Surgical Products | 2003-01-08 | 177 | 3 |
| K013013 | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. | Medtronic Cardiac Surgical Products | 2001-12-04 | 88 | 1 |
| K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LIN | Medtronic Cardiac Surgical Products | 2001-10-24 | 106 | 0 |
| K010737 | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, M | Medtronic Cardiac Surgical Products | 2001-04-04 | 23 | 1 |
| K000776 | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP | Medtronic Cardiac Surgical Products | 2001-02-07 | 334 | 1 |
| K994171 | MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERI | Medtronic Cardiac Surgical Products | 2000-04-27 | 139 | 0 |
| K000274 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE | Medtronic Cardiac Surgical Products | 2000-02-10 | 10 | 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