Cleared Traditional

VitalFlowTM Centrifugal Pump

K223898 · Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · Cardiovascular

Aug 2023

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K223898 is an FDA 510(k) clearance for the VitalFlowTM Centrifugal Pump, 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, 240 days after receiving the submission on December 28, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K223898 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2022
Decision Date	August 25, 2023
Days to Decision	240 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.