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Programmable Stimulator 5326

by Medtronic Vascular

510(k) K843718

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843718 Date27 Sep 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JOQ
Device class
Class II
Regulation
21 CFR Part 870.1750
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Programmable Stimulator 5326 is a Generator, Pulse, Pacemaker, External Programmable device designed for electrophysiological studies only. It is a Class II medical device with special controls that delivers programmable electrical stimulation for diagnostic purposes in cardiovascular applications.

This device is manufactured by Medtronic Vascular and was FDA 510(k) cleared on September 27, 1984 with product code JOQ. It is supplied as a standalone device without specific information on sterility, single-use status, or MRI safety. The device is stored according to manufacturer specifications and is authorized for use in cardiovascular electrophysiological studies.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Programmable Stimulator 5326 used for?

    The Programmable Stimulator 5326 is designed specifically for electrophysiological studies in cardiovascular applications. It delivers programmable electrical stimulation for diagnostic purposes only, making it a specialized tool for cardiovascular research and testing.

  • How is the Programmable Stimulator 5326 supplied and what are its storage requirements?

    The device is supplied as a standalone unit without specific information on sterility or single-use status. It should be stored according to the manufacturer's specifications to maintain proper functionality, though detailed storage conditions are not provided in the available documentation.

  • What is the regulatory status of the Programmable Stimulator 5326?

    The Programmable Stimulator 5326 is a Class II medical device with special controls that received FDA 510(k) clearance on September 27, 1984. It has product code JOQ and was determined to be substantially equivalent to predicate devices for cardiovascular electrophysiological studies.

  • Is the Programmable Stimulator 5326 suitable for MRI environments?

    The available documentation does not specify MRI safety information for the Programmable Stimulator 5326. Users should consult the manufacturer directly or refer to the most current product information regarding MRI compatibility before use in such environments.