510(k) K162214 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Protek Solo 24 Fr Venous Cannula Set
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Nov 30, 2016 |
| Received | Aug 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2019 | Cardiac Assist, Inc TandemLife ECLS Procedure Kit - V24/A17, Catalog Number
5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s ven Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.