510(k) K090555 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Dec 23, 2009 |
| Received | Mar 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2014 | Maquet Cardiovascular Us Sales, Llc MAQUET PLEGIOX Cardioplegia Heat Exchanger
The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given t Terminated |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.