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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 K133631
Device Name LEXIPLIANT DILATOR SHEATH SET
Applicant
Spectranetics Corporation
9965 Federal Dr.
Colorado Springs,  CO  80921 -3617
Applicant Contact STACEY A STRAND
Correspondent
Spectranetics Corporation
9965 Federal Dr.
Colorado Springs,  CO  80921 -3617
Correspondent Contact STACEY A STRAND
Regulation Number870.1310
Classification Product Code
DRE  
Date Received11/26/2013
Decision Date 03/27/2014
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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