510(k) K213435

MAGIC Flow-Dependent Microcatheter by Balt USA, LLC — Product Code KRA

K213435 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "MAGIC Flow-Dependent Microcatheter". The FDA issued a decision of Substantially Equivalent on July 19, 2022. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Balt USA, LLC has at least 10 other 510(k) clearances on record.