510(k) K093522 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Dec 7, 2009 |
| Received | Nov 13, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.