The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Hollow Fiber Oxygenator With Trillium Biopassive Surface.
| Device ID | K973760 |
| 510k Number | K973760 |
| Device Name: | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | AVECOR CARDIOVASCULAR, INC. 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Dennis E Steger |
| Correspondent | Dennis E Steger AVECOR CARDIOVASCULAR, INC. 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-02 |
| Decision Date | 1998-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994865971 | K973760 | 000 |
| 20613994375630 | K973760 | 000 |
| 20613994375623 | K973760 | 000 |
| 20681490791100 | K973760 | 000 |
| 20721902673331 | K973760 | 000 |
| 20721902648896 | K973760 | 000 |