The following data is part of a premarket notification filed by American Bentley with the FDA for Blood Cardioplegia Stainless Steel Cool.
| Device ID | K831157 |
| 510k Number | K831157 |
| Device Name: | BLOOD CARDIOPLEGIA STAINLESS STEEL COOL |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-08 |
| Decision Date | 1983-05-09 |