510(k) K031662

PRESSURE WIRE SENSOR, MODELS 12004/12304 by Radi Medical Systems AB — Product Code DXO

K031662 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSURE WIRE SENSOR, MODELS 12004/12304". The FDA issued a decision of Substantially Equivalent on June 6, 2003. 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.