510(k) K052081 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
| Applicant | Estech, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Aug 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Sorin Group USA, Inc. FlexFlow Venous Cannula Model/Catalog Number 200-200
The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.