510(k) K100278 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Apr 30, 2010 |
| Received | Feb 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
BEQ-HMOD30000-USA 701070397
BEQ-HMOD30000-USA 701050330 Open, Classified |
DTZ | None listed |
| Nov 13, 2019 | GETINGE US SALES LLC Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile
REF: BEQ-HMOD 30000 Open, Classified |
DTZ | None listed |
| Dec 24, 2014 | Maquet Cardiovascular Us Sales, Llc Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000
For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carb Terminated |
DTZ | None listed |
| Jan 11, 2012 | Maquet Cardiovascular Us Sales, Llc MAQUET QUADROX iD PEDIATRIC -OXYGENATOR:
BEQ-HMOD 3000; Made In Germany
The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenato Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.