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 |