The following data is part of a premarket notification filed by Jostra Medizintechnik Ag with the FDA for Rotaflow Centrifugal Pump System.
| Device ID | K991864 |
| 510k Number | K991864 |
| Device Name: | ROTAFLOW CENTRIFUGAL PUMP SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | JOSTRA MEDIZINTECHNIK AG 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Contact | Kathy Johnson |
| Correspondent | Kathy Johnson JOSTRA MEDIZINTECHNIK AG 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 2000-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691000824 | K991864 | 000 |