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510(k) Data Aggregation
K Number
K150472Device Name
NxStage System One
Manufacturer
NXSTAGE MEDICAL, INC.
Date Cleared
2015-06-04
(101 days)
Product Code
ODN
Regulation Number
876.5860Why did this record match?
Product Code :
ODN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Device Description
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.
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K Number
K141752Device Name
NXSTAGE SYSTEM ONE
Manufacturer
NXSTAGE MEDICAL, INC.
Date Cleared
2014-12-19
(172 days)
Product Code
ODN
Regulation Number
876.5860Why did this record match?
Product Code :
ODN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Device Description
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.
Ask a Question
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