Quantum Perfusion Arterial Cannula Graft

Catheter, Cannula And Tubing, Vascular, 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 Arterial Cannula Graft.

Pre-market Notification Details

Device IDK203057
510k NumberK203057
Device Name:Quantum Perfusion Arterial Cannula Graft
ClassificationCatheter, Cannula And Tubing, Vascular, 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 CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-08
Decision Date2021-06-30

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