FDA 510(k)

MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula

K-Number: K251258 · 2025-06-20

Decision Date2025-06-20

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2025-06-20 under approval number K251258. 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 MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula?

MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Medtronic, Inc.. The 510(k) number is K251258.

When was MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula approved by the FDA?

MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula received FDA 510(k) clearance on 2025-06-20, under approval number K251258.

What company makes MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula?

MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula is manufactured by Medtronic, Inc..

What is the FDA product code for MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula?

The FDA product code for MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula is DWF.

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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.