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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K112032
Device Name 8FR TURBO - TANDEM SYSTEM
Applicant
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact SHELLEY WILCOX
Correspondent
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact SHELLEY WILCOX
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
MCW  
Date Received07/15/2011
Decision Date 10/17/2011
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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