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510(k) Data Aggregation
K Number
K051599Device Name
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
Manufacturer
Date Cleared
2005-07-19
(33 days)
Product Code
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
NEURORECOVERY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Neurorecovery™, Inc., Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.
Device Description
The Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is composed of many permanently connected components that incorporate a transducer for connection to an ICP monitoring device. The NRI CIPER™ Kit incorporates components of a cleared intracranial pressure monitoring device, an intracranial pressure transducer, and many components of the Neurorecovery™ Main Valve Assembly. The NRI CIPER™ Kit is designed to be used with the Neurorecovery " Main Valve Assembly. It is provided to the user sterile, non-pyrogenic (fluid path), single use, disposable, and not recommended for reuse of any kind.
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K Number
K022638Device Name
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
Manufacturer
Date Cleared
2002-10-31
(84 days)
Product Code
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
NEURORECOVERY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Neurorecovery™, Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.
Device Description
The Neurorecovery", Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit consists of legally marketed ventricular catheter, stylet, trocar, valves, tubing, associated connectors, caps, check-valves, needle-free valve, and stopcocks.
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