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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K090913
Device Name CROSS-PILOT TURBO ELITE SUPPORT CATHETER
Applicant
SPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs,  CO  80921
Applicant Contact BRANDON HANSEN
Correspondent
SPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs,  CO  80921
Correspondent Contact BRANDON HANSEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/01/2009
Decision Date 05/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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