Decision Date2021-06-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Quantum Perfusion Arterial Cannula Graft is the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2021-06-30 under 510(k) 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. The listed applicant is Qura S.R.L. The 510(k) number is K203057.
When did Quantum Perfusion Arterial Cannula Graft receive FDA 510(k) clearance?
Quantum Perfusion Arterial Cannula Graft received FDA 510(k) clearance on 2021-06-30, under 510(k) number K203057.
Who is the listed applicant for Quantum Perfusion Arterial Cannula Graft?
The FDA 510(k) record lists Qura S.R.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Quantum Perfusion Arterial Cannula Graft?
The FDA product code for Quantum Perfusion Arterial Cannula Graft is DWF.
Other records listing Qura S.R.L as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1UK233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsK221353Quantum 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-VSK213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set View all 15 devices →
Related Devices (Code: DWF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.