The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Venous Reservior Bag.
Device ID | K935717 |
510k Number | K935717 |
Device Name: | AFFINITY VENOUS RESERVIOR BAG |
Classification | Reservoir, Blood, 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 | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-30 |
Decision Date | 1994-05-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50613994010792 | K935717 | 000 |