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U.S. Department of Health and Human Services

Product Classification
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Device catheter, ventricular (containing antibiotic or antimicrobial agents)
Regulation Description Ventricular catheter.
Definition Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNHC
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.4100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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