The following data is part of a premarket notification filed by American Bentley with the FDA for Cardiotomy/mediastinal Auto. Reservoir Catr-3500.
| Device ID | K872167 |
| 510k Number | K872167 |
| Device Name: | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 |
| Classification | Defoamer, 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 | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-09-01 |