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510(k) Data Aggregation
K Number
K223898Device Name
VitalFlowTM Centrifugal Pump
Manufacturer
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.)
Date Cleared
2023-08-25
(240 days)
Product Code
QNR, ONR
Regulation Number
870.4100Why did this record match?
Applicant Name (Manufacturer) :
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VitalFlow™ Centrifugal Pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in adult 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.
The VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.
Device Description
The VitalFlow Centrifugal Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated toward the outlet of the pump.
The VitalFlow Centrifugal Pump can be driven through magnetic coupling by an External Drive Motor or the Emergency Handcrank.
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K Number
K230364Device Name
VitalFlow Console
Manufacturer
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.)
Date Cleared
2023-08-25
(196 days)
Product Code
QNR
Regulation Number
870.4100Why did this record match?
Applicant Name (Manufacturer) :
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VitalFlow™ Console controls the VitalFlow™ Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult 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. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.
Device Description
The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal life support (ECLS) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for ECLS circuit data only; no patient data are stored or exported.
The VitalFlow Emergency Handcrank (drive unit) can be used in emergency situations to manually drive the centrifugal pump in the case of console and or motor drive failure.
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