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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 K233483
Device Name FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
Applicant
Cardio Flow Inc.,
3530 88th Ave. NE
Blaine,  MN  55014
Applicant Contact Michael Kallok
Correspondent
Medical Devices Pathway, LLC
14330 178th Ln. NE
Woodinville,  WA  98072
Correspondent Contact Caitlyn Dzhafarov
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/27/2023
Decision Date 02/15/2024
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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