Cleared Traditional

MAGIC Infusion Catheter

K202366 · Balt USA, LLC · Neurology
Jan 2021
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K202366 is an FDA 510(k) clearance for the MAGIC Infusion Catheter, 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 January 29, 2021, 163 days after receiving the submission on August 19, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K202366 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2020
Decision Date January 29, 2021
Days to Decision 163 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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