The following data is part of a premarket notification filed by American Bentley with the FDA for Cardiotomy Reservoir W/filter Bcr-3500.
| Device ID | K842620 |
| 510k Number | K842620 |
| Device Name: | CARDIOTOMY RESERVOIR W/FILTER BCR-3500 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-05 |
| Decision Date | 1984-08-27 |