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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 K152694
Device Name Diamondback 360 Peripheral Orbital Atherectomy System
Applicant
Cardiovascular Systems Inc.
1225 Old Highway 8 NW
Saint Paul,  MN  55112
Applicant Contact Kim Wallner
Correspondent
Cardiovascular Systems Inc.
1225 Old Highway 8 NW
Saint Paul,  MN  55112
Correspondent Contact Kim Wallner
Regulation Number870.4875
Classification Product Code
MCW  
Date Received09/21/2015
Decision Date 10/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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