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 |