510(k) K210838

PROWLER SELECT PLUS; PROWLER EX by Medos International SARL — Product Code KRA

K210838 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "PROWLER SELECT PLUS; PROWLER EX". The FDA issued a decision of Substantially Equivalent on August 25, 2021. 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.