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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 K250385
Device Name Turbo-Elite Laser Atherectomy Catheter
Applicant
Spectranetics
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Katie Adamski
Correspondent
Spectranetics
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Katie Adamski
Regulation Number870.4875
Classification Product Code
MCW  
Date Received02/11/2025
Decision Date 03/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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