510(k) K850077

MEDTRONIC 5311 PACING SYSTEM ANALYZER by Medtronic Vascular — Product Code DTC

K850077 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC 5311 PACING SYSTEM ANALYZER". The FDA issued a decision of Substantially Equivalent on July 16, 1985. 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.