Cleared Traditional

MAGIC Flow-Dependent Microcatheter

K213435 · Balt USA, LLC · Neurology
Jul 2022
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K213435 is an FDA 510(k) clearance for the MAGIC Flow-Dependent Microcatheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on July 19, 2022, 270 days after receiving the submission on October 22, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K213435 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2021
Decision Date July 19, 2022
Days to Decision 270 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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