510(k) K103191 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Mar 8, 2011 |
| Received | Oct 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Maquet Medical Systems USA QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388 Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388 Open, Classified |
DTR | 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.