Cleared Traditional

Wallaby 017 Micro Catheter

K223139 · Wallaby Medical · Neurology
Apr 2023
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K223139 is an FDA 510(k) clearance for the Wallaby 017 Micro Catheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on April 25, 2023, 203 days after receiving the submission on October 4, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K223139 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2022
Decision Date April 25, 2023
Days to Decision 203 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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