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 |