The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Arterial Canalization Device.
| Device ID | K820516 |
| 510k Number | K820516 |
| Device Name: | ARTERIAL CANALIZATION DEVICE |
| Classification | Catheter, Percutaneous |
| Applicant | ALIMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-25 |
| Decision Date | 1982-04-15 |