The following data is part of a premarket notification filed by American Bentley with the FDA for Cardioplegia Heat Exchanger He-100.
| Device ID | K840045 |
| 510k Number | K840045 |
| Device Name: | CARDIOPLEGIA HEAT EXCHANGER HE-100 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-06 |
| Decision Date | 1984-02-13 |