V-STICK VASCULAR ACCESS SET

Introducer, Catheter

ARGON MEDICAL

The following data is part of a premarket notification filed by Argon Medical with the FDA for V-stick Vascular Access Set.

Pre-market Notification Details

Device IDK130730
510k NumberK130730
Device Name:V-STICK VASCULAR ACCESS SET
ClassificationIntroducer, Catheter
Applicant ARGON MEDICAL 3600 SW 47TH AVE Gainesville,  FL  32608
ContactJennifer Bonacci
CorrespondentJennifer Bonacci
ARGON MEDICAL 3600 SW 47TH AVE Gainesville,  FL  32608
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-18
Decision Date2013-11-22
Summary:summary

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