510(k) K190557 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Bio-Medicus Insertion Kit
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 3, 2019 |
| Received | Mar 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2021 | Medtronic Perfusion Systems Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.