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U.S. Department of Health and Human Services

Product Classification

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Device external cerebrospinal fluid (csf) diversion
Regulation Description Cerebrospinal fluid shunt system.
Definition Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Physical State CSF drainage system.
Technical Method Diverts CSF in order to alter spinal cord perfusion pressures.
Target Area Central nervous system (CNS) subarachnoid and ventricular space.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePCB
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible