The following data is part of a premarket notification filed by American Bentley with the FDA for Cardioplegia Heat Exchanger Holder He-100sh.
| Device ID | K854113 |
| 510k Number | K854113 |
| Device Name: | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-08 |
| Decision Date | 1986-01-08 |