FDA 510(k)

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae

K-Number: K162215 · 2017-06-16

Decision Date2017-06-16

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2017-06-16 under approval number K162215. 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 Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae?

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K162215.

When was Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae approved by the FDA?

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae received FDA 510(k) clearance on 2017-06-16, under approval number K162215.

What company makes Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae?

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae?

The FDA product code for Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae is DWF.

Other Devices by Sorin Group Italia S.R.L.

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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 K171308Tubing PackMedtronic, Inc.

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.