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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K203424
Device Name Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
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 Number870.4350
Classification Product Code
DTZ  
Date Received11/20/2020
Decision Date 12/17/2021
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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