The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Angio-flo Contin-arterial Flush Dev..
Device ID | K832058 |
510k Number | K832058 |
Device Name: | ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. |
Classification | Catheter, Continuous Flush |
Applicant | PARKE-DAVIS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-27 |
Decision Date | 1983-09-12 |