Cleared Traditional

VitalFlow Set with Balance Biosurface

K240880 · Medtronic, Inc. · Cardiovascular
Sep 2024
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K240880 is an FDA 510(k) clearance for the VitalFlow Set with Balance Biosurface, a Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure (Class II — Special Controls, product code QJZ), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 12, 2024, 164 days after receiving the submission on April 1, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K240880 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2024
Decision Date September 12, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QJZ — Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4100
Definition Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure.