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FDA 510(k)

Venous Return Cannulae

K-Number: K250937 · 2026-03-11

ApplicantLivaNova USA, Inc.
Decision Date2026-03-11
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Venous Return Cannulae is a medical device manufactured by LivaNova USA, Inc.. It received FDA 510(k) clearance on 2026-03-11 under approval number K250937. 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 Venous Return Cannulae?

Venous Return Cannulae is a medical device that received FDA 510(k) clearance on 2026-03-11. It is manufactured by LivaNova USA, Inc.. The 510(k) number is K250937.

When was Venous Return Cannulae approved by the FDA?

Venous Return Cannulae received FDA 510(k) clearance on 2026-03-11, under approval number K250937.

What company makes Venous Return Cannulae?

Venous Return Cannulae is manufactured by LivaNova USA, Inc..

What is the FDA product code for Venous Return Cannulae?

The FDA product code for Venous Return Cannulae is DWF.

Related Clinical Trials

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Other Devices by LivaNova USA, Inc.

K233702SMARxT Tubing and Connectors K250283RAP Femoral Venous Cannulae PMA P970003Stimulator, autonomic nerve, implanted for epilepsy PMA P250013Stimulator, hypoglossal nerve, implanted, apnea

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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