510(k) K082117 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Feb 18, 2009 |
| Received | Jul 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Maquet Medical Systems USA QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 70000-USA 701067820
HMO 71000-USA 7010678 Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 70000-USA 701067820
HMO 71000-USA 701067823 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 |
| Sep 20, 2013 | Maquet Cardiovascular Us Sales, Llc QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation d Terminated |
DTZ | None listed |
| Oct 26, 2012 | Maquet Cardiovascular Us Sales, Llc QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000
Product Usage:
The QUADROX oxygenators are intended for the use in extracor Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.