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U.S. Department of Health and Human Services

Product Classification

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Device port & catheter, implanted, subcutaneous, intraventricular
Regulation Description Central nervous system fluid shunt and components.
Regulation Medical Specialty Neurology
Review Panel General Hospital
Product CodeLKG
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 882.5550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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