Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1750](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1750) → JOQ — Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

# JOQ · Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

_Cardiovascular · 21 CFR 870.1750 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ

## Overview

- **Product Code:** JOQ
- **Device Name:** Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- **Regulation:** [21 CFR 870.1750](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1750)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Life-sustaining:** yes

## Recent Cleared Devices (19 of 19)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K173439](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K173439.md) | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | Mar 29, 2018 | SESE |
| [K092913](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K092913.md) | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | Ep Medsystems | Oct 16, 2009 | SESE |
| [K072200](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K072200.md) | STIMLAB | Micropace Pty, Ltd. | Oct 26, 2007 | SESE |
| [K070743](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K070743.md) | Z6 STIMULATOR | St Cardio Technologies, LLC | Jul 2, 2007 | SESE |
| [K041442](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K041442.md) | EP-4 CLINICAL STIMUTATOR | Ep Medsystems | Sep 14, 2004 | SESE |
| [K040207](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K040207.md) | EP-4 CLINICAL STIMULATOR | Ep Medsystems | Feb 27, 2004 | SESE |
| [K011826](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K011826.md) | EPS320 CARDIAC STIMULATOR | Micropace Pty, Ltd. | Jan 24, 2002 | SESE |
| [K991293](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K991293.md) | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR | Fischer Medical Technologies, Inc. | May 5, 2000 | SESE |
| [K963579](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K963579.md) | PACE-1A CARDIAC STIMULATOR | Radionics, Inc. | Nov 8, 1996 | SESE |
| [K935590](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K935590.md) | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR | Ep Medical, Inc. | May 5, 1994 | SESE |
| [P920032](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/P920032.md) | MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER | Pace Medical | Mar 10, 1994 | APPR |
| [K900553](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K900553.md) | CONSTANT CURRENT STIMULATOR MODEL 022101 | Ep Technologies, Inc. | Mar 13, 1990 | SESE |
| [K893094](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K893094.md) | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM | Heartware Intl. Corp. | Oct 2, 1989 | SESE |
| [K861368](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K861368.md) | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR | Medtronic Vascular | Aug 4, 1986 | SESE |
| [K852746](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K852746.md) | EXTERNAL PACEMAKER TELECTRONICS TE200 | Seamed Corp. | Sep 12, 1985 | SESE |
| [K844815](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K844815.md) | CORDIS ELECTROPHYSIOLOGY STIMULATOR | Cordis Corp. | Jun 11, 1985 | SESE |
| [K851091](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K851091.md) | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR | Medtronic Vascular | Apr 16, 1985 | SESE |
| [K843718](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K843718.md) | PROGRAMMABLE STIMULATOR 5326 | Medtronic Vascular | Sep 27, 1984 | SESE |
| [K833421](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ/K833421.md) | PROGRAMMABLE STIMULATOR 2352 | Medtronic Vascular | Jan 30, 1984 | SESE |

## Top Applicants

- Medtronic Vascular — 4 clearances
- Ep Medsystems — 3 clearances
- Micropace Pty, Ltd. — 2 clearances
- Cordis Corp. — 1 clearance
- Ep Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/JOQ)

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