510(k) K062769

PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 by Radi Medical Systems AB — Product Code DXO

K062769 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSUREWIRE CERTUS, MODELS 12006 AND 12306". The FDA issued a decision of Substantially Equivalent on December 4, 2006. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Radi Medical Systems AB has at least 10 other 510(k) clearances on record.