The following data is part of a premarket notification filed by American Bentley with the FDA for Cardioplegia Heat Exchanger Model No. He-100.
| Device ID | K870804 |
| 510k Number | K870804 |
| Device Name: | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-27 |
| Decision Date | 1987-09-01 |