510(k) K843718

PROGRAMMABLE STIMULATOR 5326 by Medtronic Vascular — Product Code JOQ

K843718 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "PROGRAMMABLE STIMULATOR 5326". The FDA issued a decision of Substantially Equivalent on September 27, 1984. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
September 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device Class
Class II
Regulation Number
870.1750
Review Panel
CV
Submission Type