STENT GRAFT BALLOON CATHETER

Catheter, Percutaneous

VIA BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Via Biomedical, Inc. with the FDA for Stent Graft Balloon Catheter.

Pre-market Notification Details

Device IDK091624
510k NumberK091624
Device Name:STENT GRAFT BALLOON CATHETER
ClassificationCatheter, Percutaneous
Applicant VIA BIOMEDICAL, INC. 6655 WEDGEWOOD RD, SUITE 150 Maple Grove,  MN  55311
ContactFernando Di Caprio
CorrespondentFernando Di Caprio
VIA BIOMEDICAL, INC. 6655 WEDGEWOOD RD, SUITE 150 Maple Grove,  MN  55311
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-03
Decision Date2009-10-15
Summary:summary

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