510(k) K082519

FINECROSS MG CORONARY MICRO-GUIDE CATHETER by Terumo Medical Corp. — Product Code KRA

K082519 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "FINECROSS MG CORONARY MICRO-GUIDE CATHETER". The FDA issued a decision of Substantially Equivalent on September 26, 2008. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.