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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K082981
Device Name DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
Applicant
Cardiovascular Systems, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact DAVID D BROOKE
Correspondent
Cardiovascular Systems, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact DAVID D BROOKE
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/06/2008
Decision Date 10/31/2008
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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