FLIXENE IFG VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

ATRIUM MEDICAL CORPORATION

The following data is part of a premarket notification filed by Atrium Medical Corporation with the FDA for Flixene Ifg Vascular Graft.

Pre-market Notification Details

Device IDK130142
510k NumberK130142
Device Name:FLIXENE IFG VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant ATRIUM MEDICAL CORPORATION 5 WENTWORTH DR Hudson,  NH  03051
ContactMegan Mccagh, Rac, Ctbs
CorrespondentMegan Mccagh, Rac, Ctbs
ATRIUM MEDICAL CORPORATION 5 WENTWORTH DR Hudson,  NH  03051
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-22
Decision Date2013-03-15

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