510(k) K132829 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
| Applicant | Maquet Cardiopulmonary, AG, Wayne NJ, US |
| Decision | Substantially Equivalent, Oct 8, 2013 |
| Received | Sep 9, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2015 | Maquet Cardiovascular Us Sales, Llc Quadrox-iD Adult Diffusion Membrane Oxygenator
Product Usage:
The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.