DTE
Medtronic Model 5392 External Pulse Generator (EPG)
- Advisory panel
- Cardiovascular
- Total cleared
- 65
Adverse events under product code DTE
product code DTE- Death
- 18
- Injury
- 247
- Malfunction
- 4,603
- Total
- 4,868
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DTE
- K241781 — Solo Pace Control
- K232721 — Lifetech Cardio Temporary Pacemaker
- K201011 — Medtronic Model 5392 External Pulse Generator (EPG)
- K190825 — Medtronic Model 5392 External Pulse Generator (EPG)
- K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker
- K181973 — Medtronic Model 5392 External Pulse Generator (EPG)
- K180873 — Medtronic Model 53401 External Pulse Generator (EPG)
- K162054 — Medtronic Temporary External Pacemaker 53401
- K162550 — Medtronic Model 5392 External Pulse Generator (EPG)
- K150246 — Medtronic Model 5392 External Pulse Generator (EPG)
- K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
- K123916 — PSA SERIES
- K042708 — ERA 3000 PACING SYSTEM ANALYZER
- K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
- K023080 — GALIX PACESTAR
- K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
- K020896 — OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
- K011980 — ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
- K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
- K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
- K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
- K971474 — MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
- K964190 — ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K970497 — PACE 101H
- K960676 — ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
- K940467 — REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
- K934016 — POWERCHARGER
- K925143 — MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
- K923621 — EXTERNAL DEMAND PACEMAKER
- K923398 — CPI MODEL 2215
- K915364 — CHRONOCOR VI MODEL 5012
- K913805 — MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
- K912507 — CPI MODEL 2215 & SEAMED MODEL 3400
- K910237 — MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
- K902679 — MODELS 4201, 4231 & 4235 EXTENSION CABLES
- K900220 — TRANS-PACE 100
- K896352 — MODEL EC4542G MINIATURE
- K893633 — MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
- K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
- K872551 — SEAMED MODEL 3200
- K871915 — MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
- K853194 — ERA-20
- K870323 — MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
- K863903 — SEA MED MODEL 6000
- K854648 — SEAMED MODEL 4000
- K850822 — CHRONOCOR V EXTERNAL PACER, MODEL 297A
- K843777 — SEAMED 4000
- K843807 — SEAMED MODEL 6000
- K831768 — EXTERNAL PULSE GENERATOR FOR TEMP. STIM
- K831381 — RAPID ATRIAL PACER
- K823048 — SEA MED MODEL 880
- K821791 — EXTERNAL PULSE GENERATOR - EV4542
- K820570 — SEAMED, #540 - SIEMENS, #146F TELECTRO
- K811092 — STERILE PACKAGING
- K810566 — SIEMENS MODEL 146-146A EXTERNAL PULSE G
- K803313 — PACING SYSTEM ANALYZER
- K802221 — CHRONOCOR IV MODEL 250
- K801055 — COMPUPACE, 524-01 PACER SYSTEM COMPUTER
- K801953 — EXTERNAL, TEMP. PORTABLE CARDIAC GENER
- K801596 — CYNERGY MODEL 184
- K792536 — CYNERGY MODEL 182
- K800088 — PACEMAKER ELECTRODE INSERTER AIDE
- K792223 — PACESETTER MODEL 350
- K782108 — MEDTRONIC MODEL 546
- K781327 — PULSE GENERATOR, MODEL 240, EXTERNAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.