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

Oxygenator, Cardiopulmonary Bypass

Qura S.r.l.

The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for 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.

Pre-market Notification Details

Device IDK203424
510k NumberK203424
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
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Qura S.r.l. Via Di Mezzo, 23 Mirandola,  IT 41037
ContactRaffaella Tommasini
CorrespondentRaffaella Tommasini
Qura S.r.l. Via Di Mezzo, 23 Mirandola,  IT 41037
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-20
Decision Date2021-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08051160300747 K203424 000
08051160300730 K203424 000
08051160300686 K203424 000
08051160300679 K203424 000

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