510(k) K981995 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
QUICKDRAW VENOUS CANNULA
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Apr 20, 1999 |
| Received | Jun 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981995
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2019 | Edwards Lifesciences, LLC QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705 Terminated |
DWF | None listed |
| Jun 13, 2013 | Edwards Lifesciences, LLC QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannu Terminated |
DWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.