The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Cp Centrifugal Blood Pump, Affinity Cp Centrifugal Blood Pump With Balance Biosurface, Affinity Cp Centrifugal Blood Pump With Cortiva Bioactive Surface.
| Device ID | K201068 |
| 510k Number | K201068 |
| Device Name: | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortiva BioActive Surface |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Sammie C. Joseph-fredericks |
| Correspondent | Sammie C. Joseph-fredericks Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-22 |
| Decision Date | 2020-05-21 |