510(k) K954457

MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER by Medi-Tech, Inc. — Product Code KRA

K954457 is an FDA 510(k) premarket notification submitted by Medi-Tech, Inc. for the device "MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on May 15, 1996. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Medi-Tech, Inc. has at least 10 other 510(k) clearances on record.