510(k) K153246

PTFE Super Sheath Introducer 2.1 by Medcomp (Medical Components, Inc.) — Product Code DYB

K153246 is an FDA 510(k) premarket notification submitted by Medcomp (Medical Components, Inc.) for the device "PTFE Super Sheath Introducer 2.1". The FDA issued a decision of Substantially Equivalent on February 12, 2016. 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.