The following data is part of a premarket notification filed by Micor, Inc. with the FDA for Angiography Catheters.
Device ID | K854018 |
510k Number | K854018 |
Device Name: | ANGIOGRAPHY CATHETERS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MICOR, INC. 9229 PANNIER RD. Pittsburgh, PA 15237 |
Contact | Stephen Brushey |
Correspondent | Stephen Brushey MICOR, INC. 9229 PANNIER RD. Pittsburgh, PA 15237 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-30 |
Decision Date | 1986-01-16 |