ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

ANGIODYNAMICS, INC.

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

Pre-market Notification Details

Device IDK072196
510k NumberK072196
Device Name:ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactTeri Juckett
CorrespondentTeri Juckett
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-07
Decision Date2007-08-27
Summary:summary

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