The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Arterial Blood Filter.
| Device ID | K952532 |
| 510k Number | K952532 |
| Device Name: | AFFINITY ARTERIAL BLOOD FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| 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 | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-01 |
| Decision Date | 1995-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50613994011539 | K952532 | 000 |
| 50613994011249 | K952532 | 000 |
| 20643169858835 | K952532 | 000 |
| 20643169767762 | K952532 | 000 |