510(k) K130730

V-STICK VASCULAR ACCESS SET by Argon Medical — Product Code DYB

K130730 is an FDA 510(k) premarket notification submitted by Argon Medical for the device "V-STICK VASCULAR ACCESS SET". The FDA issued a decision of Substantially Equivalent on November 22, 2013. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2013
Date Received
March 18, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type