510(k) K073166

ENDOWAVE INFUSION SYSTEM by Ekos Corp. — Product Code KRA

K073166 is an FDA 510(k) premarket notification submitted by Ekos Corp. for the device "ENDOWAVE INFUSION SYSTEM". The FDA issued a decision of SESU on April 22, 2008. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Ekos Corp. has at least 10 other 510(k) clearances on record.