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Found 4 results
510(k) Data Aggregation
K Number
K062508Device Name
NEUROWAVE MICRO-INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2006-12-05
(99 days)
Product Code
NUI
Regulation Number
870.1200Why did this record match?
Product Code :
NUI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Device Description
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
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K Number
K053437Device Name
EKOS MICRO-INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2006-01-06
(28 days)
Product Code
NUI
Regulation Number
870.1200Why did this record match?
Product Code :
NUI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EKOS Micro- Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Device Description
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
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K Number
K051225Device Name
EKOS MICRO-INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2005-06-10
(29 days)
Product Code
NUI
Regulation Number
870.1200Why did this record match?
Product Code :
NUI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Device Description
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
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K Number
K041826Device Name
EKOS ULTRASOUND INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2005-04-27
(294 days)
Product Code
NUI
Regulation Number
870.1200Why did this record match?
Product Code :
NUI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Device Description
The EKOS Micro-Infusion System is an infusion catheter system designed to deliver ultrasound energy through a transducer element at the distal catheter tip. This device is intended to deliver angiographic contrast material into the neurovasculature.
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