Cleared Traditional

Bio-Medicus Life Support Catheter and Introducer

K240534 · Medtronic, Inc. · Cardiovascular
Apr 2024
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K240534 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. (Mounds View, US). The FDA issued a Cleared decision on April 19, 2024, 53 days after receiving the submission on February 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K240534 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2024
Decision Date April 19, 2024
Days to Decision 53 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.