510(k) K062396 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
MODIFICATION TO STOCKERT S5 SYSTEM
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Sep 28, 2006 |
| Received | Aug 16, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2010 | Sorin Group USA, Inc. Mast Roller Pump, Catalog 50-80-00, 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.