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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 K043465
FOIA Releasable 510(k) K043465
Device Name 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Applicant Contact ADRIAN E ELFE
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Correspondent Contact ADRIAN E ELFE
Regulation Number870.1250
Classification Product Code
PDU  
Date Received12/15/2004
Decision Date 08/18/2005
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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