510(k) K202366

MAGIC Infusion Catheter by Balt USA, LLC — Product Code KRA

K202366 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "MAGIC Infusion Catheter". The FDA issued a decision of Substantially Equivalent on January 29, 2021. 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.