510(k) K211110

Agile Devices Angler Steerable, Deflectable Microcatheter by Agile Devices, Inc. — Product Code KRA

K211110 is an FDA 510(k) premarket notification submitted by Agile Devices, Inc. for the device "Agile Devices Angler Steerable, Deflectable Microcatheter". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210.