510(k) K132943

INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE by Synaptic Medical Limited — Product Code DRC

K132943 is an FDA 510(k) premarket notification submitted by Synaptic Medical Limited for the device "INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on August 29, 2014. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Synaptic Medical Limited has at least 2 other 510(k) clearances on record.