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510(k) Data Aggregation
K Number
K133624Device Name
COMPASS CT, COMPASS CT PORT
Manufacturer
MIRADOR BIOMEDICAL
Date Cleared
2014-04-18
(143 days)
Product Code
DRS, DXG
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
MIRADOR BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
Device Description
The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.
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K Number
K112203Device Name
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
Manufacturer
MIRADOR BIOMEDICAL, INC.
Date Cleared
2011-12-14
(135 days)
Product Code
DRS, DXG
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
MIRADOR BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compass™ GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The Compass™ Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
Device Description
The Compass devices are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass devices are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
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K Number
K103715Device Name
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
Manufacturer
MIRADOR BIOMEDICAL, INC.
Date Cleared
2011-01-20
(30 days)
Product Code
DRS
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
MIRADOR BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K101518Device Name
COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
Manufacturer
MIRADOR BIOMEDICAL, INC.
Date Cleared
2010-10-13
(133 days)
Product Code
DRS, DXG
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
MIRADOR BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.
The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.
Device Description
The Compass is a disposable, point-of-use pressure measurement and monitoring device that incorporates a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass is provided as two different models, each corresponding to a specific indication for use:
- (1) The Compass Vascular Access (VA) is for invasive blood pressure measurement and monitoring during the insertion of vascular access devices.
- (2) The Compass Lumbar Puncture (LP) is for intracranial pressure measurement and monitoring via lumbar puncture or intraventricular catheter.
Both models are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
The Compass VA and Compass LP devices are identical except for two differences: 1) the measurement units in which the pressure is displayed on the LCD (mm Hg for blood pressure measurements with the Compass VA and cm H2O for intracranial pressure measurements with the Compass LP), and 2) the Compass VA blood pressure monitoring device has a proximal port through which commercially available guidewires can be inserted during pressure measurement.
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