510(k) K202141

Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set by Argon Medical Devices, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2021
Date Received
July 31, 2020
Clearance Type
Traditional
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