The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Rotaflow Centrifugal Pump With Safeline Coating, Model Bsq-rf-32.
| Device ID | K061072 |
| 510k Number | K061072 |
| Device Name: | ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenkgienks |
| Correspondent | Katrin Schwenkgienks MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-05-23 |
| Summary: | summary |