ADVANTA SST BIFURCATED GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Advanta Sst Bifurcated Graft.

Pre-market Notification Details

Device IDK020767
510k NumberK020767
Device Name:ADVANTA SST BIFURCATED GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactKaren Hall
CorrespondentKaren Hall
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-08
Decision Date2002-04-03

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