510(k) K132498

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

K132498 is an FDA 510(k) premarket notification submitted by Medcomp (Medical Components, Inc.) for the device "VALVED TEARAWAY INTRODUCER GENERATION II". The FDA issued a decision of Substantially Equivalent on November 25, 2013. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medcomp (Medical Components, Inc.) has at least 5 other 510(k) clearances on record.