Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set

Introducer, Catheter

Argon Medical Devices, Inc.

The following data is part of a premarket notification filed by Argon Medical Devices, Inc. with the FDA for Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set.

Pre-market Notification Details

• Device ID: K202141
• 510k Number: K202141
• Device Name: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
• Classification: Introducer, Catheter
• Applicant: Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751
• Contact: Amy Clendening-wheeler
• Correspondent: Amy Clendening-wheeler; Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-31
• Decision Date: 2021-01-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00886333225729	K202141	000
00886333225552	K202141	000