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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K052296
Device Name CLIRPATH TURBO EXCIMER LASER CATHETERS
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907 -5159
Applicant Contact NEIL BURRIS
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907 -5159
Correspondent Contact NEIL BURRIS
Regulation Number870.1250
Classification Product Code
PDU  
Date Received08/23/2005
Decision Date 09/02/2005
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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