The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Rotaflow Centrifugal Pump With Softline Coating, Model Bo-rf-32 (usa).
| Device ID | K090515 |
| 510k Number | K090515 |
| Device Name: | ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Frank Moehrke |
| Correspondent | Frank Moehrke MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-02-26 |
| Decision Date | 2009-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691650333 | K090515 | 000 |