ANGIOTECH CVC

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

ANGIOTECH PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Angiotech Pharmaceuticals, Inc. with the FDA for Angiotech Cvc.

Pre-market Notification Details

Device IDK073520
510k NumberK073520
Device Name:ANGIOTECH CVC
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant ANGIOTECH PHARMACEUTICALS, INC. 13921 PARK CENTER ROAD SUITE 100 Herndon,  VA  20171
ContactTrudy D Estridge
CorrespondentTrudy D Estridge
ANGIOTECH PHARMACEUTICALS, INC. 13921 PARK CENTER ROAD SUITE 100 Herndon,  VA  20171
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2007-12-14
Decision Date2008-04-11
Summary:summary

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