510(k) K010737 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
| Applicant | Medtronic Cardiac Surgical Products, Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 4, 2001 |
| Received | Mar 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010737
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using E Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.