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U.S. Department of Health and Human Services

Product Classification
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Device brain intraparenchymal infusion cannula
Definition A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy.
Physical State A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device made of various materials (e.g., ceramics, polymers, or metals).
Technical Method A brain intraparenchymal infusion cannula is guided to a target in the brain by stereotaxic navigation and used to deliver a therapy (e.g., biologic or drug product) by connection of the cannula to an infusion pump system.
Target Area Brain parenchyma tissue.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeSDG
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.4110
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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