Programmer, Pacemaker
FDA product code KRG · Class III (high risk) · 21 CFR 870.3700 · Cardiovascular
25510(k) clearances
0PMA approvals
8recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | Intermedics, Inc. | 03/15/1995SE |
| K884522 | Model 5650 Optimate Personal ProgrammerKRG · Traditional | Teletronics, Inc. | 08/25/1989SE |
| K880738 | Model 2331T Patient ProgrammerKRG · Traditional | Medtronic Vascular | 11/17/1988SE |
| K882429 | Model 255A Programmer III, W/Software Revi. 4004KRG · Traditional | Tpl-Cordis, Inc. | 07/22/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | Telectronics, Inc. | 12/17/1987SE |
| K871986 | Model 5600B Programmer, PacemakerKRG · Traditional | Telectronics, Inc. | 06/24/1987SE |
| K863046 | Ultra Software Module: Model 2016KRG · Traditional | Cardiac Pacemakers, Inc. | 12/05/1986SE |
| K863045 | Programmer Model 2035/ELECTROGRAM Cable Model 6580KRG · Traditional | Cardiac Pacemakers, Inc. | 09/29/1986SE |
| K860584 | Software MODULE/2035 Prog and Astra/T Pulse GenKRG · Traditional | Cardiac Pacemakers, Inc. | 06/06/1986SE |
| K860546 | Dialog Programmer 700 - Program Version 6.37KRG · Traditional | Pacesetter Systems | 04/23/1986SE |
| K844484 | Hewlett Packardt HP 85 W/ Vitatron PH1 Program HeaKRG · Traditional | Vitatron Medical BV | 07/24/1985SE |
| K844485 | CERYX6, 611, Ceryx 3 311 & Ceryx 1 111KRG · Traditional | Vitatron Medical BV | 04/19/1985SE |
| K844483 | TP 1KRG · Traditional | Vitatron Medical BV | 04/19/1985SE |
| K842364 | Handheld Pacemaker Programmer & SoftwarKRG · Traditional | Cardiac Pacemakers, Inc. | 09/24/1984SE |
| K820230 | Pacemaker Programmer 2030KRG · Traditional | Cardiac Pacemakers, Inc. | 03/15/1982SE |
| K812761 | Flow-Directed Balloon ThermodilutionKRG · Traditional | Nova Medical Specialties | 11/02/1981SE |
| K812813 | Intermedics Programmer, Model 522-03KRG · Traditional | Intermedics, Inc. | 10/27/1981SE |
| K811217 | Pacemaker Programmer #2010KRG · Traditional | Cardiac Pacemakers, Inc. | 07/20/1981SE |
| K810552 | Cordis Pacemaker Programmers 255A & 256AKRG · Traditional | Cordis Corp. | 03/20/1981SE |
| K800376 | EPR-200 Programmer Model 010KRG · Traditional | Biotronik Sales, Inc. | 04/21/1980SE |
| K792580 | Pacemaker ProgrammerKRG · Traditional | Cardiac Pacemakers, Inc. | 12/19/1979SE |
| K791419 | Omnicor Programmer Model 222CKRG · Traditional | Cordis Corp. | 11/27/1979SE |
| K790220 | Pacemaker ProgrammerKRG · Traditional | Intermedics, Inc. | 07/31/1979SE |
| K780175 | Rate Programmer Model 520KRG · Traditional | Intermedics, Inc. | 04/21/1978SE |
| K771855 | Omnicor Programmer Model 222AKRG · Traditional | Cordis Corp. | 10/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2128-2025 Class II | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number…A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update… | Medtronic, Inc. | 06/17/2025Open, Classified |
| Z-2127-2025 Class II | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967…A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update… | Medtronic, Inc. | 06/17/2025Open, Classified |
| Z-0413-2017 Class II | The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to…Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS… | Sorin Group USA, Inc. | 09/29/2016Terminated |
| Z-0412-2017 Class II | The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to…Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS… | Sorin Group USA, Inc. | 09/29/2016Terminated |
| Z-0017-2011 | Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac…Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become… | Boston Scientific CRM Corp | 07/22/2010Terminated |
| Z-1557-2010 | VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT…Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital… | Boston Scientific CRM Corp | 03/15/2010Terminated |
| Z-0297-2007 | St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical…St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510… | St Jude Medical CRMD | 10/06/2006Terminated |
| Z-0296-2007 | St. Jude Medical APS III Programmer, used in combination with St. Jude Medical…St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510… | St Jude Medical CRMD | 10/06/2006Terminated |