510(k) K101153 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Dec 8, 2010 |
| Received | Apr 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMOD 70000-USA 701067840
BEQ-HMOD70000-USA 701067859 Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067840 Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass
Item no. 701067859 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.