510(k) K120617

PTFE SUPER SHEATH INTRODUCER by Martech Medical Products — Product Code DYB

K120617 is an FDA 510(k) premarket notification submitted by Martech Medical Products for the device "PTFE SUPER SHEATH INTRODUCER". The FDA issued a decision of Substantially Equivalent on November 19, 2012. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Martech Medical Products has at least 10 other 510(k) clearances on record.