510(k) K141432 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
| Applicant | Maquet Cardiopulmonary, AG, Rastatt De-Bw, DE |
| Decision | Substantially Equivalent, Jul 7, 2014 |
| Received | May 30, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.