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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K123452
Device Name TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM
Applicant
Stryker
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact JEAN CHEN
Correspondent
Stryker
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact JEAN CHEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/08/2012
Decision Date 01/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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