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510(k) Data Aggregation
K Number
K030470Device Name
NXSTAGE SYSTEM ONE
Manufacturer
NXSTAGE MEDICAL, INC.
Date Cleared
2003-07-07
(145 days)
Product Code
FII
Regulation Number
876.5860Why did this record match?
Product Code :
FII
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
Device Description
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration.
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