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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K140775
Device Name TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
Applicant
Spectranetics Corporation
9965 Federal Dr.
Colorado Springs,  CO  80921 -3617
Applicant Contact AMANDA JOHNSON
Correspondent
Spectranetics Corporation
9965 Federal Dr.
Colorado Springs,  CO  80921 -3617
Correspondent Contact AMANDA JOHNSON
Regulation Number870.4875
Classification Product Code
MCW  
Subsequent Product Code
DQY  
Date Received03/28/2014
Decision Date 07/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01330628
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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