3F ANGIOPTIC ANGIOGRAPHIC CATHETER

Catheter, Intravascular, Diagnostic

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for 3f Angioptic Angiographic Catheter.

Pre-market Notification Details

Device IDK964033
510k NumberK964033
Device Name:3F ANGIOPTIC ANGIOGRAPHIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactBrian Kunst
CorrespondentBrian Kunst
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-08
Decision Date1997-05-06

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