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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 K190634
Device Name Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
Applicant
Cardiovascular Systems, Inc.
1225 Old Hwy. 8 NW
St.Paul,  MN  55112
Applicant Contact Kris Miller
Correspondent
Cardiovascular Systems, Inc.
1225 Old Hwy. 8 NW
St.Paul,  MN  55112
Correspondent Contact Kris Miller
Regulation Number870.4875
Classification Product Code
MCW  
Date Received03/12/2019
Decision Date 07/02/2019
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
Recalls CDRH Recalls
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