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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 Highway 8 NW
St. Paul,  MN  55112
Applicant Contact Kris Miller
Correspondent
Cardiovascular Systems Inc.
1225 Old Highway 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
Recalls CDRH Recalls
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