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FDA 510(k)

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

K-Number: K251258 · 2025-06-20

ApplicantMedtronic, Inc.
Decision Date2025-06-20
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K251258.

When did MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula receive FDA 510(k) clearance?

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

Who is the listed applicant for MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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.

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