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510(k) DEN240023

SmartFlow Neuro Cannula by ClearPoint Neuro, Inc. — Product Code SDG

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 13, 2024
Date Received
May 22, 2024
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brain Intraparenchymal Infusion Cannula
Device Class
Class II
Regulation Number
882.4110
Review Panel
NE
Submission Type

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.

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