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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 -5159
Applicant Contact MICHAEL K HANDLEY
Correspondent
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS,  CO  80907 -5159
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
Recalls CDRH Recalls
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