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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