510(k) K124046

VALVED TEARAWAY INTRODUCER GENERATION II by Medical Components, Inc. — Product Code DYB

K124046 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "VALVED TEARAWAY INTRODUCER GENERATION II". The FDA issued a decision of Substantially Equivalent on June 3, 2013. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medical Components, Inc. has at least 10 other 510(k) clearances on record.