ADVANTA SUPER SOFT GRAFT

Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

ATRIUM MEDICAL CORP.

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

Pre-market Notification Details

Device IDK000504
510k NumberK000504
Device Name:ADVANTA SUPER SOFT GRAFT
ClassificationProsthesis, Vascular Graft, Of Less Then 6mm 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 CodeDYF  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-15
Decision Date2000-03-01

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