Brain Intraparenchymal Infusion Cannula

SDG · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4110

Classification

FDA Product Code: SDG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4110
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown