The following data is part of a premarket notification filed by American Bentley with the FDA for Arterial Blood Filter Holder Model No. Af-he.
| Device ID | K862549 |
| 510k Number | K862549 |
| Device Name: | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-07-15 |