510(k) K171308 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Tubing Pack
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jun 2, 2017 |
| Received | May 3, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171308
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2018 | Medtronic Perfusion Systems Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.