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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 K180416
Device Name ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
Applicant
Cardiovascular Systems Inc.
1225 Old Highway 8 NW
Saint Paul,  MN  55112
Applicant Contact Susan Wolf
Correspondent
Cardiovascular Systems Inc.
1225 Old Highway 8 NW
Saint Paul,  MN  55112
Correspondent Contact Susan Wolf
Regulation Number870.4875
Classification Product Code
MCW  
Date Received02/15/2018
Decision Date 04/17/2018
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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