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510(k) Data Aggregation
K Number
K040021Device Name
SHUNTCHECK (PROMETHEUS 1)
Manufacturer
Date Cleared
2004-11-02
(301 days)
Product Code
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
SAMUEL NEFF M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ShuntCheck is indicated for the detection of flow in implanted silastic cerebrospinal Shuid (CSF) shunts. ShuntCheck must be used by a qualified neurosurgeon according to instructions. ShuntCheck cannot, alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.
Device Description
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