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 IDK202141
510k NumberK202141
Device Name:Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
ClassificationIntroducer, Catheter
Applicant Argon Medical Devices, Inc. 1445 Flat Creek Road Athens,  TX  75751
ContactAmy Clendening-wheeler
CorrespondentAmy Clendening-wheeler
Argon Medical Devices, Inc. 1445 Flat Creek Road Athens,  TX  75751
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2021-01-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886333225729 K202141 000
00886333225552 K202141 000

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