510(k) K151936

Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle by Synaptic Medical Limited — Product Code DYB

K151936 is an FDA 510(k) premarket notification submitted by Synaptic Medical Limited for the device "Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle". The FDA issued a decision of Substantially Equivalent (kit) on December 4, 2015. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Synaptic Medical Limited has at least 2 other 510(k) clearances on record.