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 |