The following data is part of a premarket notification filed by American Bentley with the FDA for Cardiotomy Reservors Bcr-3000/3500-q-120.
| Device ID | K834373 |
| 510k Number | K834373 |
| Device Name: | CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-12 |
| Decision Date | 1984-02-04 |