510(k) K861368

MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR by Medtronic Vascular — Product Code JOQ

K861368 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on August 4, 1986. The device falls under product code JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)), a Class II device regulated under 21 CFR 870.1750. Medtronic Vascular has at least 10 other 510(k) clearances on record.