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510(k) Data Aggregation
K Number
K192169Device Name
PulsioFlex Monitoring System with ProAQT Sensor
Manufacturer
Pulsion Medical Systems SE
Date Cleared
2020-04-30
(265 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
Pulsion Medical Systems SE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed.
- With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
- With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
- With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring.
The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.
Device Description
The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
a) PulsioFlex Monitor
b) PiCCO Module
c) CeVOX Optical Module
d) ProAQT Sensor
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K Number
K171620Device Name
PiCCO Catheter
Manufacturer
PULSION Medical Systems SE
Date Cleared
2018-02-21
(264 days)
Product Code
KRB
Regulation Number
870.1915Why did this record match?
Applicant Name (Manufacturer) :
PULSION Medical Systems SE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement.
PiCCO Catheters are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
Device Description
The PiCCO Catheter uses a thermistor to measure the blood temperature change during thermodilution. This thermistor is located in one of the two catheter lumen. The second catheter lumen ends in a Luer-Lock for connection to a pressure monitoring kit.
The thermistor is connected to a patient monitor via a dedicated plug.
The placement of the catheter into a large arterial vessel is done using the Seldinger Technique and is intended to use of up to 10 days.
The PiCCO Catheter Sets contain the following parts:
1. PiCCO Catheter,
2. Guidewire with dispenser and advancer,
3. Introducer needles,
4. Dilator (exception: the 3F Set does not include a dilator).
Five PiCCO Catheter models are available which differ in diameter and length. The PiCCO catheter set contains accessories fitting to the respective PiCCO catheter model in size.
The Catheter Set is packed into a preformed blister (PET), sealed with a Tyvek® lid and EtO sterilized.
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K Number
K172259Device Name
PulsioFlex Monitoring System
Manufacturer
PULSION Medical Systems SE
Date Cleared
2018-01-18
(175 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
PULSION Medical Systems SE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's data are entered, the PulsioFlex monitor presents the derived parameters indexed.
With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.
Device Description
The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
a) PulsioFlex Monitor
b) CeVOX Optical Module
c) PICCO Module
The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.
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K Number
K122121Device Name
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
Manufacturer
PULSION MEDICAL SYSTEMS SE
Date Cleared
2012-08-02
(16 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
PULSION MEDICAL SYSTEMS SE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
Device Description
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
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