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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 K092396
Device Name SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
Applicant
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS,  CO  80907 -5159
Applicant Contact CHERYL HASTINGS
Correspondent
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS,  CO  80907 -5159
Correspondent Contact CHERYL HASTINGS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/05/2009
Decision Date 09/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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