510(k) K253741

V•Stick™ Vascular Access Set by Argon Medical Devices, Inc. — Product Code DYB

K253741 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "V•Stick™ Vascular Access Set". The FDA issued a decision of Substantially Equivalent on December 15, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2025
Date Received
November 24, 2025
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