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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 K170059
Device Name Spectranetics Turbo-Elite Laser Atherectomy Catheters
Applicant
Spectranetics, Inc.
9965 Federal Drive
Colorado Springs,  CO  80921
Applicant Contact Rebecca Spelich
Correspondent
Spectranetics, Inc.
9965 Federal Drive
Colorado Springs,  CO  80921
Correspondent Contact Rebecca Spelich
Regulation Number870.4875
Classification Product Code
MCW  
Date Received01/06/2017
Decision Date 04/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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