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 |