FDA 510(k) Applications for Medical Device Product Code "DTE"
(Pulse-Generator, Pacemaker, External)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K964190 | BIOTRONIK, INC. | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | 07/10/1997 |
| K042708 | BIOTRONIK, INC. | ERA 3000 PACING SYSTEM ANALYZER | 10/20/2004 |
| K023080 | GALIX BIOMEDICAL INSTRUMENTATION, INC. | GALIX PACESTAR | 06/11/2003 |
| K971474 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL | 07/14/1997 |
| K150246 | Medtronic, Inc | Medtronic Model 5392 External Pulse Generator (EPG) | 02/18/2015 |
| K132924 | MEDTRONIC, INC. | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | 10/31/2013 |
| K180873 | Medtronic, Inc. | Medtronic Model 53401 External Pulse Generator (EPG) | 04/19/2018 |
| K201011 | Medtronic, Inc. | Medtronic Model 5392 External Pulse Generator (EPG) | 05/13/2020 |
| K162550 | Medtronic, Inc. | Medtronic Model 5392 External Pulse Generator (EPG) | 10/12/2016 |
| K181973 | Medtronic, Inc. | Medtronic Model 5392 External Pulse Generator (EPG) | 08/21/2018 |
| K190825 | Medtronic, Inc. | Medtronic Model 5392 External Pulse Generator (EPG) | 04/30/2019 |
| K162054 | MEDTRONIC, INC. | Medtronic Temporary External Pacemaker 53401 | 10/18/2016 |
| K022939 | OSYPKA MEDICAL, INC. | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES | 10/03/2002 |
| K020896 | OSYPKA MEDICAL, INC. | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE | 06/14/2002 |
| K033130 | OSYPKA MEDICAL, INC. | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | 10/31/2003 |
| K123916 | OSYPKA MEDICAL, INC. | PSA SERIES | 04/09/2013 |
| K011980 | PACE MEDICAL | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 | 09/12/2001 |
| K002204 | PACE MEDICAL | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | 10/18/2000 |
| K001180 | PACE MEDICAL | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 | 06/27/2000 |
| K970347 | PALADIN MEDICAL, INC. | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | 08/29/1997 |
| K182839 | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | Lifetech Cardio Model 8301 Temporary Pacemaker | 02/28/2019 |
| K970497 | SULZER OSCOR, INC. | PACE 101H | 06/04/1997 |
| K960676 | ZOLL MEDICAL CORP. | ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 | 06/05/1996 |
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