510(k) K092463 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Nov 5, 2009 |
| Received | Aug 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2010 | Sorin Group USA, Inc. B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.