510(k) K910595

MODEL 5311B A-V PACING SYSTEM ANALYZER by Medtronic Vascular — Product Code DTC

K910595 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 5311B A-V PACING SYSTEM ANALYZER". The FDA issued a decision of Substantially Equivalent on May 7, 1991. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Medtronic Vascular has at least 10 other 510(k) clearances on record.