510(k) K153598 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Bio-Medicus Adult Cannula Kit
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jan 15, 2016 |
| Received | Dec 16, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2026 | Medtronic Perfusion Systems Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.