Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Quantum Perfusion Arterial Cannula Graft

K-Number: K203057 · 2021-06-30

ApplicantQura S.R.L
Decision Date2021-06-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Perfusion Arterial Cannula Graft is a medical device manufactured by Qura S.R.L. It received FDA 510(k) clearance on 2021-06-30 under approval number K203057. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Perfusion Arterial Cannula Graft?

Quantum Perfusion Arterial Cannula Graft is a medical device that received FDA 510(k) clearance on 2021-06-30. It is manufactured by Qura S.R.L. The 510(k) number is K203057.

When was Quantum Perfusion Arterial Cannula Graft approved by the FDA?

Quantum Perfusion Arterial Cannula Graft received FDA 510(k) clearance on 2021-06-30, under approval number K203057.

What company makes Quantum Perfusion Arterial Cannula Graft?

Quantum Perfusion Arterial Cannula Graft is manufactured by Qura S.R.L.

What is the FDA product code for Quantum Perfusion Arterial Cannula Graft?

The FDA product code for Quantum Perfusion Arterial Cannula Graft is DWF.

Related Clinical Trials

NCT04325230 Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy COMPLETED NCT07595627 Hypothermic Machine Perfusion for Liver Graft Preservation NOT_YET_RECRUITING NCT07585890 Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe RECRUITING NCT07554599 Nonoinvasive HPI in Beach-chair Position NOT_YET_RECRUITING NCT07556588 XVIVO Heart Transplant Study in Clinical Practice RECRUITING NCT06485596 HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. ACTIVE_NOT_RECRUITING

Other Devices by Qura S.R.L

K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 K203424Quantum 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 K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS

View all 15 devices →

Related Devices (Code: DWF)

K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. K171979Tubing PackMedtronic, Inc. K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 FrSurge Cardiovascular K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑