The following data is part of a premarket notification filed by American Bentley with the FDA for Cardiotomy/mediastinal Autotransfusion Reservoir.
| Device ID | K852382 |
| 510k Number | K852382 |
| Device Name: | CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR |
| Classification | Reservoir, Blood, 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 | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-05 |
| Decision Date | 1985-09-25 |