510(k) K131452

PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 by St. Jude Medical Systems AB — Product Code DXO

K131452 is an FDA 510(k) premarket notification submitted by St. Jude Medical Systems AB for the device "PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300". The FDA issued a decision of Substantially Equivalent on September 5, 2013. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. St. Jude Medical Systems AB has at least 4 other 510(k) clearances on record.