Cleared Traditional

Bio-Medicus Life Support Catheter and Introducer

K251831 · Medtronic, Inc. · Cardiovascular
Jan 2026
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K251831 is an FDA 510(k) clearance for the Bio-Medicus Life Support Catheter and Introducer, a Single Lumen Ecmo Cannula (Class II — Special Controls, product code QHW), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 15, 2026, 216 days after receiving the submission on June 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K251831 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2025
Decision Date January 15, 2026
Days to Decision 216 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QHW — Single Lumen Ecmo Cannula
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4100
Definition Single-lumen Cannulas/catheters To Be Used With An Extracorporeal Circuit Intended For Use In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.