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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 Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 882.4100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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