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Found 4 results
510(k) Data Aggregation
K Number
K112323Device Name
CARDIA-CATH
Manufacturer
MILLAR INSTRUMENTS, INC.
Date Cleared
2011-10-18
(67 days)
Product Code
DXO
Regulation Number
870.2870Why did this record match?
Applicant Name (Manufacturer) :
MILLAR INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system
Device Description
The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.
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K Number
K093111Device Name
MIKRO-CATH, MODEL 825-0101
Manufacturer
MILLAR INSTRUMENTS, INC.
Date Cleared
2010-01-05
(96 days)
Product Code
DXO
Regulation Number
870.2870Why did this record match?
Applicant Name (Manufacturer) :
MILLAR INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the hurnan body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.
Device Description
The Mikro-Cath is a disposable/single use, sterile cardiovascular pressure catheter transducer for monitoring and measuring pressure anywhere in the cardiovascular system with an appropriately sized guide catheter.
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K Number
K013205Device Name
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
Manufacturer
MILLAR INSTRUMENTS, INC.
Date Cleared
2002-07-02
(280 days)
Product Code
DRQ, DRO
Regulation Number
870.2060Why did this record match?
Applicant Name (Manufacturer) :
MILLAR INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel
Device Description
The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor.
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K Number
K993694Device Name
MIKRO-TIP ANGIOGRAPHIC CATHETER
Manufacturer
MILLAR INSTRUMENTS, INC.
Date Cleared
2000-03-01
(120 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
MILLAR INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Millar Angiographic catheter is designed to provide high fidelity pressure readings and deliver radiopaque contrast medium to selected sites in the vascular system.
Device Description
Not Found
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