510(k) K871297

KADIR HI-TORQUE GUIDE WIRE by Argon Medical Corp. — Product Code KOD

K871297 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "KADIR HI-TORQUE GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on April 10, 1987. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Argon Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type