Cleared Traditional

Micro Catheter

K243534 · Suzhou Zenith Vascular SciTech Limited · Neurology
Jul 2025
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K243534 is an FDA 510(k) clearance for the Micro Catheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Suzhou Zenith Vascular SciTech Limited (Suzhou, CN). The FDA issued a Cleared decision on July 30, 2025, 257 days after receiving the submission on November 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K243534 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2024
Decision Date July 30, 2025
Days to Decision 257 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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