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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 K072750
Device Name SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
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
DQY  
Date Received09/27/2007
Decision Date 12/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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