510(k) K844555
K844555 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "PATHFINDER CARDIOVASCULAR CATHETER". The FDA issued a decision of Substantially Equivalent on March 27, 1985. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Argon Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1985
- Date Received
- November 21, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type