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510(k) Data Aggregation
K Number
K112448Device Name
PULSIOFLEX
Manufacturer
PULSION MEDICAL SYSTEMS, INC.
Date Cleared
2011-09-22
(28 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
PULSION MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.
Device Description
PulsioFlex Monitoring System with Optional CeVox ™ Accessories
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K Number
K001762Device Name
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
Manufacturer
PULSION MEDICAL SYSTEMS, INC.
Date Cleared
2000-06-13
(4 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
PULSION MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991886Device Name
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
Manufacturer
PULSION MEDICAL SYSTEMS, INC.
Date Cleared
2000-05-11
(344 days)
Product Code
KRB
Regulation Number
870.1915Why did this record match?
Applicant Name (Manufacturer) :
PULSION MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor is 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 monitorinq is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
Device Description
The PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor used as accessories to the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO). When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO), the above device accessories, in connection with a central venous catheter, operate to measure and display cardiac output parameters.
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