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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 K071226
Device Name 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Applicant Contact MICHAEL K HANDLEY
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Correspondent Contact MICHAEL K HANDLEY
Regulation Number870.1250
Classification Product Code
PDU  
Date Received05/03/2007
Decision Date 06/29/2007
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
Recalls CDRH Recalls
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