510(k) K082344 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Aug 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082344
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2010 | Sorin Group USA, Inc. Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.