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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 K212688
Device Name Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
Applicant
Qura S.r.l.
Via di Mezzo, 23
Mirandola,  IT 41037
Applicant Contact Raffaella Tommasini
Correspondent
Qura S.r.l.
Via di Mezzo, 23
Mirandola,  IT 41037
Correspondent Contact Raffaella Tommasini
Regulation Number870.4240
Classification Product Code
DTR  
Date Received08/25/2021
Decision Date 01/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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