Cleared Special

Ventricular Catheter

K200950 · Aesculap, Inc. · Neurology
May 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K200950 is an FDA 510(k) clearance for the Ventricular Catheter, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 8, 2020, 29 days after receiving the submission on April 9, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K200950 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2020
Decision Date May 08, 2020
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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