510(k) K002962

PRESSURE WIRE SENSOR, MODEL 12003/12303 by Radi Medical Systems AB — Product Code DQX

K002962 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSURE WIRE SENSOR, MODEL 12003/12303". The FDA issued a decision of Substantially Equivalent on October 4, 2000. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Radi Medical Systems AB has at least 10 other 510(k) clearances on record.