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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 K052514
Device Name CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Applicant Contact NEIL BURRIS
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Correspondent Contact NEIL BURRIS
Regulation Number870.1250
Classification Product Code
PDU  
Date Received09/14/2005
Decision Date 10/19/2005
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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