The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Blood Pump System.
Device ID | K964017 |
510k Number | K964017 |
Device Name: | AFFINITY BLOOD PUMP SYSTEM |
Classification | Console, Heart-lung Machine, 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 | DTQ |
CFR Regulation Number | 870.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-07 |
Decision Date | 1997-08-05 |
Summary: | summary |