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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 K033678
Device Name SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Applicant Contact MICHAEL J RYAN
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Correspondent Contact MICHAEL J RYAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/24/2003
Decision Date 02/23/2004
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
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