510(k) K090511 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Jun 12, 2009 |
| Received | Feb 26, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067829 Open, Classified |
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.