510(k) K111943

AGILLS PF DELIVERY SYSTEM by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DYB

K111943 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "AGILLS PF DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 29, 2011. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. St. Jude Medical, Cardiac Rhythm Management Divisi has at least 9 other 510(k) clearances on record.