The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Avecor Pre-bypass Filter.
Device ID | K940126 |
510k Number | K940126 |
Device Name: | AVECOR PRE-BYPASS FILTER |
Classification | Filter, Prebypass, 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 | KRJ |
CFR Regulation Number | 870.4280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-10 |
Decision Date | 1994-06-28 |