The following data is part of a premarket notification filed by American Bentley with the FDA for Heparin-coated Extracorporeal Circuits.
| Device ID | K861641 |
| 510k Number | K861641 |
| Device Name: | HEPARIN-COATED EXTRACORPOREAL CIRCUITS |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-30 |
| Decision Date | 1986-09-29 |