ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics Angiostent Biliary Stent System.

Pre-market Notification Details

Device IDK982346
510k NumberK982346
Device Name:ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactBrian Kunst
CorrespondentBrian Kunst
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-06
Decision Date1999-01-29

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