The following data is part of a premarket notification filed by American Bentley with the FDA for Blood Tubing(pvc) 201458 W/(totm) Plasticizer.
| Device ID | K850925 |
| 510k Number | K850925 |
| Device Name: | BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER |
| Classification | Catheter, Cannula And Tubing, Vascular, 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 | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-05-21 |