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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K142546
Device Name TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
Applicant
SPECTRANETICS, INC.
9965 FEDERAL DRIVE
COLORADO SPRINGS,  CO  80921
Applicant Contact Christopher McLellan
Correspondent
SPECTRANETICS, INC.
9965 FEDERAL DRIVE
COLORADO SPRINGS,  CO  80921
Correspondent Contact Christopher McLellan
Regulation Number870.1310
Classification Product Code
DRE  
Date Received09/10/2014
Decision Date 09/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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