510(k) K210808

Instylla Microcatheter 1.2 by Instylla, Inc. — Product Code KRA

K210808 is an FDA 510(k) premarket notification submitted by Instylla, Inc. for the device "Instylla Microcatheter 1.2". The FDA issued a decision of Substantially Equivalent on April 15, 2021. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Instylla, Inc. has at least 9 other 510(k) clearances on record.