The following data is part of a premarket notification filed by American Bentley with the FDA for Arterial Blood Filter Af-1040-af-1040bl.
| Device ID | K830132 |
| 510k Number | K830132 |
| Device Name: | ARTERIAL BLOOD FILTER AF-1040-AF-1040BL |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | AMERICAN BENTLEY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-12 |
| Decision Date | 1983-01-28 |