510(k) K214025

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter by Medos International SARL — Product Code KRA

K214025 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter". The FDA issued a decision of Substantially Equivalent on April 12, 2022. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Medos International SARL has at least 10 other 510(k) clearances on record.