510(k) K841926

HYDROGLIDE SPRING GUIDE WIRES by Argon Medical Corp. — Product Code DQX

K841926 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "HYDROGLIDE SPRING GUIDE WIRES". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Argon Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
May 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type