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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 K161333
Device Name TightRail Sub-C Rotating Dilator Sheath
Applicant
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Stephanie Byrum
Correspondent
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Stephanie Byrum
Regulation Number870.1310
Classification Product Code
DRE  
Date Received05/12/2016
Decision Date 07/08/2016
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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