Cleared Traditional

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

K251258 · Medtronic, Inc. · Cardiovascular

Jun 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K251258 is an FDA 510(k) clearance for the MC2? Two-Stage Venous Cannula; MC2X? Three-Stage Venous Cannula, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 20, 2025, 58 days after receiving the submission on April 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K251258 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2025
Decision Date	June 20, 2025
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210