510(k) K140466

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

K140466 is an FDA 510(k) premarket notification submitted by St. Jude Medical Systems AB for the device "PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300". The FDA issued a decision of Substantially Equivalent on November 13, 2014. 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.