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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 K072800
Device Name DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Applicant
Cardiovascular Systems, Inc.
18555 37th Ave. N.
Plymouth,  MN  55446
Applicant Contact JOHN CARLINE
Correspondent
Cardiovascular Systems, Inc.
18555 37th Ave. N.
Plymouth,  MN  55446
Correspondent Contact JOHN CARLINE
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/01/2007
Decision Date 10/25/2007
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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