The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affiity Cp Centrifugal Blood Pump.
| Device ID | K100631 |
| 510k Number | K100631 |
| Device Name: | AFFIITY CP CENTRIFUGAL BLOOD PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Sue Fidler |
| Correspondent | Sue Fidler 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 | 2010-03-05 |
| Decision Date | 2010-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994776655 | K100631 | 000 |
| 00763000108274 | K100631 | 000 |
| 00763000108281 | K100631 | 000 |
| 00763000108298 | K100631 | 000 |
| 00643169745001 | K100631 | 000 |
| 00613994647832 | K100631 | 000 |
| 20613994647843 | K100631 | 000 |
| 00613994647870 | K100631 | 000 |
| 00613994776594 | K100631 | 000 |
| 00613994776617 | K100631 | 000 |
| 00613994776624 | K100631 | 000 |
| 00613994776631 | K100631 | 000 |
| 00613994776648 | K100631 | 000 |
| 00763000301330 | K100631 | 000 |