510(k) K131079

CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC by Creganna Medical Devices — Product Code DYB

K131079 is an FDA 510(k) premarket notification submitted by Creganna Medical Devices for the device "CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC". The FDA issued a decision of Substantially Equivalent on August 1, 2013. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.