510(k) K102464 ยท DTZ Oxygenator, Cardiopulmonary Bypass
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Mar 4, 2011 |
| Received | Aug 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102464
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Maquet Medical Systems USA QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 10000-USA 701070412
HMO 11000-USA 701 Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 10000-USA 701070412
HMO 11000-USA 701070416 Open, Classified |
DTZ | None listed |
| Nov 28, 2018 | Maquet Cardiovascular Us Sales, Llc QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120
The membrane oxygenator QUADROXi Neonatal is intended for use in Terminated |
DTZ | None listed |
| Nov 28, 2018 | Maquet Cardiovascular Us Sales, Llc QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207
The membrane oxygenator QUADROXi Neonatal is intended for use in ext Terminated |
DTZ | None listed |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc QUADROX-i oxygenators
Custom tubing packs for the oxygenator Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.