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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K223879
Device Name Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Applicant
Quara S.R.L.
Via Di Mezzo, 23
Mirandola,  IT 41037
Applicant Contact Raffaella Tommasini
Correspondent
Quara S.R.L.
Via Di Mezzo, 23
Mirandola,  IT 41037
Correspondent Contact Raffaella Tommasini
Regulation Number870.4240
Classification Product Code
DTR  
Date Received12/27/2022
Decision Date 04/13/2023
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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