510(k) K160335

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D by St Jude Medical — Product Code DRF

K160335 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D". The FDA issued a decision of Substantially Equivalent on December 13, 2016. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. St Jude Medical has at least 10 other 510(k) clearances on record.