510(k) K983506

PRESSUREWIRE SENSOR, MODEL #12001 by Radi Medical Systems AB — Product Code DQX

K983506 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSUREWIRE SENSOR, MODEL #12001". The FDA issued a decision of Substantially Equivalent on February 3, 1999. 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.