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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 K231538
Device Name FreedomFlow Orbital Circumferential Atherectomy System
Applicant
Cardio Flow Inc.,
3530 88th Ave. NE
Blaine,  MN  55014
Applicant Contact Michael J. Kallok
Correspondent
Medical Devices Pathway, LLC
19420 12th Ave. NW
Shoreline,  WA  98177
Correspondent Contact Caitlyn Dzhafarov
Regulation Number870.4875
Classification Product Code
MCW  
Date Received05/30/2023
Decision Date 09/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03635190
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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