510(k) K243534

Micro Catheter by Suzhou Zenith Vascular SciTech Limited — Product Code KRA

K243534 is an FDA 510(k) premarket notification submitted by Suzhou Zenith Vascular SciTech Limited for the device "Micro Catheter". The FDA issued a decision of Substantially Equivalent on July 30, 2025. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Suzhou Zenith Vascular SciTech Limited has at least 3 other 510(k) clearances on record.