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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, diagnostic
510(k) Number K911605
Device Name TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES
Original Applicant
TARGET THERAPEUTICS
130 rio robles
p.o. box 610458
san jose,  CA  95134
Original Contact alexis ball
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/10/1991
Decision Date 07/09/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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