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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K073520
Device Name ANGIOTECH CVC
Applicant
ANGIOTECH PHARMACEUTICALS, INC.
13921 PARK CENTER ROAD
SUITE 100
HERNDON,  VA  20171
Applicant Contact TRUDY D ESTRIDGE
Correspondent
ANGIOTECH PHARMACEUTICALS, INC.
13921 PARK CENTER ROAD
SUITE 100
HERNDON,  VA  20171
Correspondent Contact TRUDY D ESTRIDGE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/14/2007
Decision Date 04/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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