ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT

Catheter, Hemodialysis, Implanted

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc., Duramax Hemodialysis Catheter And Procedure Kit.

Pre-market Notification Details

Device IDK080400
510k NumberK080400
Device Name:ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
ClassificationCatheter, Hemodialysis, Implanted
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactTeri Juckett
CorrespondentTeri Juckett
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-13
Decision Date2008-05-13
Summary:summary

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