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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 K150732
Device Name Diamondback 360 Peripheral Orbital Atherectomy System
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DRIVE
SAINT PAUL,  MN  55112
Applicant Contact Blair Buth
Correspondent
CARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DRIVE
SAINT PAUL,  MN  55112
Correspondent Contact Blair Buth
Regulation Number870.4875
Classification Product Code
MCW  
Date Received03/20/2015
Decision Date 04/13/2015
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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