The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Cvr.
| Device ID | K936003 |
| 510k Number | K936003 |
| Device Name: | AFFINITY CVR |
| Classification | Reservoir, Blood, 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 | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-16 |
| Decision Date | 1994-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994375661 | K936003 | 000 |
| 20613994375647 | K936003 | 000 |