The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Digicath.
Device ID | K831171 |
510k Number | K831171 |
Device Name: | DIGICATH |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-11 |
Decision Date | 1983-05-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIGICATH 73545046 1381200 Dead/Cancelled |
CARDIO-STAT (1984) INC. 1985-06-26 |