510(k) K133587

PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 by St. Jude Medical Systems AB — Product Code DRG

K133587 is an FDA 510(k) premarket notification submitted by St. Jude Medical Systems AB for the device "PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. St. Jude Medical Systems AB has at least 4 other 510(k) clearances on record.