The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Pathfinder Cardiovascular Catheter.
| Device ID | K844555 |
| 510k Number | K844555 |
| Device Name: | PATHFINDER CARDIOVASCULAR CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | David Baranski |
| Correspondent | David Baranski ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-21 |
| Decision Date | 1985-03-27 |