510(k) K022187

PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 by Radi Medical Systems AB — Product Code DXO

K022187 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304". The FDA issued a decision of Substantially Equivalent on September 24, 2002. 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.