The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Hollow Fiber Oxygenator.
| Device ID | K932252 |
| 510k Number | K932252 |
| Device Name: | AFFINITY HOLLOW FIBER OXYGENATOR |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1993-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994375678 | K932252 | 000 |
| 20613994375654 | K932252 | 000 |