The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Blood Pump System.
| Device ID | K964017 |
| 510k Number | K964017 |
| Device Name: | AFFINITY BLOOD PUMP SYSTEM |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | AVECOR CARDIOVASCULAR, INC. 13010 COUNTRY RD. 6 Plymouth, MN 55441 |
| Contact | Dennis E Steger |
| Correspondent | Dennis E Steger AVECOR CARDIOVASCULAR, INC. 13010 COUNTRY RD. 6 Plymouth, MN 55441 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-08-05 |
| Summary: | summary |