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MC2X Multi-Stage Venous Cannula

by Medtronic Perfusion Systems

510(k) K031776

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031776 Date25 Jul 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MC2X Multi-Stage Venous Cannula is a single-piece, wire-wound catheter designed for venous drainage during cardiopulmonary bypass surgery. It features side ports in the distal tip and a ported atrial basket to facilitate simultaneous drainage from the right atrium and the inferior vena cava.

This device is supplied as a sterile, single-use product and includes insertion depth marks to assist with positioning. It may be supplied with tubing attached and is regulated under the cardiovascular medical specialty.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the MC2X Multi-Stage Venous Cannula?

    This device is designed for venous drainage during cardiopulmonary bypass surgery. It features side ports in the distal tip and a ported atrial basket to allow for simultaneous drainage from both the right atrium and the inferior vena cava.

  • Is the MC2X Multi-Stage Venous Cannula intended for reuse?

    No, this is a single-use product. It is supplied as a sterile device and must be disposed of after a single procedure to maintain patient safety and device integrity.

  • How does the design assist with surgical positioning?

    The cannula includes integrated insertion depth marks. These markings are provided to assist the clinician with accurate positioning of the catheter during the surgical procedure.

  • Does the device come with tubing attached?

    The MC2X Multi-Stage Venous Cannula may be supplied with tubing attached, depending on the specific configuration provided.