510(k) K072583 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Apr 4, 2008 |
| Received | Sep 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072583
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.