ADVANTA SST GRAFT (>_6MM)

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 Graft (>_6mm).

Pre-market Notification Details

Device IDK010516
510k NumberK010516
Device Name:ADVANTA SST GRAFT (>_6MM)
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 Received2001-02-22
Decision Date2001-05-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.