Cleared Traditional

Bio-Medicus Life Support Catheter and Introducer

K201057 · Medtronic, Inc. · Cardiovascular
Jan 2022
Decision
633d
Days
Class 2
Risk

About This 510(k) Submission

K201057 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 January 14, 2022, 633 days after receiving the submission on April 21, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K201057 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2020
Decision Date January 14, 2022
Days to Decision 633 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.