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FDA 510(k)

PureFlex Arterial Cannulae

K-Number: K180979 · 2018-11-16

ApplicantSorin Group Italia S.R.L.
Decision Date2018-11-16
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PureFlex Arterial Cannulae is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2018-11-16 under approval number K180979. 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 PureFlex Arterial Cannulae?

PureFlex Arterial Cannulae is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K180979.

When was PureFlex Arterial Cannulae approved by the FDA?

PureFlex Arterial Cannulae received FDA 510(k) clearance on 2018-11-16, under approval number K180979.

What company makes PureFlex Arterial Cannulae?

PureFlex Arterial Cannulae is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for PureFlex Arterial Cannulae?

The FDA product code for PureFlex Arterial 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 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.

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