510(k) K990396 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
T-ANASTAFLO
| Applicant | Edwards Lifesciences Research Medical, Midvale UT, US |
| Decision | Substantially Equivalent, Oct 1, 1999 |
| Received | Feb 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25
Anastaflo shunts are intended for use in preventing i Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.