510(k) K102919 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Mar 11, 2011 |
| Received | Oct 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2023 | Maquet Medical Systems USA Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA Open, Classified |
DTZ | None listed |
| May 26, 2023 | Maquet Medical Systems USA Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA 701070445 Open, Classified |
DTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.