510(k) K150267 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
| Applicant | Maquet Cardiopulmonary, AG, Rastatt De-Bw, DE |
| Decision | Substantially Equivalent, May 7, 2015 |
| Received | Feb 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass
Item no. 701067905 Open, Classified |
DTZ | None listed |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc QUADROX-i oxygenators
Custom tubing packs for the oxygenator Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.