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FDA 510(k)

Dual Stage Venous Cannulae

K-Number: K253671 · 2026-01-30

ApplicantSorin Group Italia S.R.L.
Decision Date2026-01-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dual Stage Venous Cannulae is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2026-01-30 under approval number K253671. 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 Dual Stage Venous Cannulae?

Dual Stage Venous Cannulae is a medical device that received FDA 510(k) clearance on 2026-01-30. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K253671.

When was Dual Stage Venous Cannulae approved by the FDA?

Dual Stage Venous Cannulae received FDA 510(k) clearance on 2026-01-30, under approval number K253671.

What company makes Dual Stage Venous Cannulae?

Dual Stage Venous Cannulae is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for Dual Stage Venous Cannulae?

The FDA product code for Dual Stage Venous Cannulae is DWF.

Related Clinical Trials

NCT05729620 Evaluation of STARgraft-3 for Hemodialysis ACTIVE_NOT_RECRUITING

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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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