510(k) K833421

PROGRAMMABLE STIMULATOR 2352 by Medtronic Vascular — Product Code JOQ

K833421 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "PROGRAMMABLE STIMULATOR 2352". The FDA issued a decision of Substantially Equivalent on January 30, 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
January 30, 1984
Date Received
October 3, 1983
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