Cleared Traditional

K230364 - VitalFlow? Console
(FDA 510(k) Clearance)

K230364 · Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · Cardiovascular

Aug 2023

Decision

196d

Days

Class 2

Risk

K230364 is an FDA 510(k) clearance for the VitalFlow? Console. This device is classified as a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II — Special Controls, product code QNR).

Submitted by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (Dexter, US). The FDA issued a Cleared decision on August 25, 2023, 196 days after receiving the submission on February 10, 2023.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100. A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood 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..

Submission Details

510(k) Number	K230364 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2023
Decision Date	August 25, 2023
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QNR — Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4100
Definition	A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood 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.