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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 K113335
Device Name HEARTRAIL III GUIDING CATHETER
Original Applicant
TERUMO Corporation
44-1, 2-chome hatagaya
shibuya-ku tokyo,  JP 151-0072
Original Contact mark unterreiner
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/14/2011
Decision Date 07/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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