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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K142259
Device Name Direxion Torqueable Microcatheter
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact Mark Lanz
Correspondent
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact Mark Lanz
Regulation Number870.1210
Classification Product Code
KRA  
Date Received08/14/2014
Decision Date 09/10/2014
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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