SCORPION Portal Vein Access Set

Introducer, Catheter

Argon Medical Devices

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

Pre-market Notification Details

Device IDK213002
510k NumberK213002
Device Name:SCORPION Portal Vein Access Set
ClassificationIntroducer, Catheter
Applicant Argon Medical Devices 1445 Flat Creek Road Athens,  TX  75751
ContactScott Bishop
CorrespondentScott Bishop
Argon Medical Devices 1445 Flat Creek Road Athens,  TX  75751
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2021-10-14

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