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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K232788
Device Name INSPIRA ART100
Applicant
Inspira Technologies Oxy B.H.N. , Ltd.
2 Ha-Tidhar St.
Ra’Anana,  IL 4366504
Applicant Contact Dganit Litinsky
Correspondent
MCRA
803 7th St. NW, 3rd Floor
Washington,  DC  20005
Correspondent Contact Fernando Aguel
Regulation Number870.4380
Classification Product Code
DWA  
Date Received09/11/2023
Decision Date 05/24/2024
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
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