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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K221919
Device Name DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
Applicant
Hemodia Sas
Zi Bourgade, 85 Rue Du Chene Vert
Labege,  FR 31670
Applicant Contact Anne-Lyse Miard
Correspondent
Visamed GmbH
Kastellstr.8
Karlsruhe,  DE 76227
Correspondent Contact Arne Briest
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/01/2022
Decision Date 03/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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