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 Cortive Bioactive Surface, Medtronic External Drive Motor.
| Device ID | K191077 |
| 510k Number | K191077 |
| Device Name: | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortive BioActive Surface, Medtronic External Drive Motor |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | Medtronic Inc 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Harsh Dharamshi |
| Correspondent | Harsh Dharamshi Medtronic Inc 7611 Northland Drive Minneapolis, MN 55428 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-23 |
| Decision Date | 2019-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000244873 | K191077 | 000 |
| 00763000244866 | K191077 | 000 |