510(k) K953866

MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) by Medtronic Vascular — Product Code DXY

K953866 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)". The FDA issued a decision of ST on December 15, 1995. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Medtronic Vascular has at least 10 other 510(k) clearances on record.