510(k) K061628 ยท DTZ Oxygenator, Cardiopulmonary Bypass
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
| Applicant | Maquet Cardiopulmonary, AG, Warrington PA, US |
| Decision | Substantially Equivalent, Aug 22, 2006 |
| Received | Jun 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061628
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.