510(k) K972793

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE by Radi Medical Systems AB — Product Code DQX

K972793 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE". The FDA issued a decision of Substantially Equivalent on April 24, 1998. 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.