510(k) K991864 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
| Applicant | Jostra Medizintechnik AG, Newark DE, US |
| Decision | Substantially Equivalent, Aug 31, 2000 |
| Received | Jun 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2020 | Maquet Cardiovascular Us Sales, Llc Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood Terminated |
KFM | None listed |
| Dec 3, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.