Pulse-Generator, Pacemaker, External

FDA product code DTE · 64 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3600
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-12-11 – 2025-01-10

DTE 2025-01-10

Solo Pace Control

Applicant Solo Pace, Inc.

K number K241781

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DTE 2024-01-07

Lifetech Cardio Temporary Pacemaker

Applicant Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

K number K232721

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DTE 2020-05-13

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K number K201011

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DTE 2019-04-30

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K number K190825

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DTE 2019-02-28

Lifetech Cardio Model 8301 Temporary Pacemaker

Applicant Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

K number K182839

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DTE 2018-08-21

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K number K181973

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DTE 2018-04-19

Medtronic Model 53401 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K number K180873

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DTE 2016-10-18

Medtronic Temporary External Pacemaker 53401

Applicant Medtronic, Inc.

K number K162054

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DTE 2016-10-12

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K number K162550

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DTE 2013-10-31

MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)

Applicant Medtronic, Inc.

K number K132924

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DTE 2013-04-09

PSA SERIES

Applicant Osypka Medical, Inc.

K number K123916

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DTE 2004-10-20

ERA 3000 PACING SYSTEM ANALYZER

Applicant Biotronik, Inc.

K number K042708

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DTE 2003-10-31

PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

Applicant Osypka Medical, Inc.

K number K033130

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DTE 2003-06-11

GALIX PACESTAR

Applicant Galix Biomedical Instrumentation, Inc.

K number K023080

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DTE 2002-10-03

OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES

Applicant Osypka Medical, Inc.

K number K022939

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DTE 2002-06-14

OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE

Applicant Osypka Medical, Inc.

K number K020896

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DTE 2001-09-12

ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825

Applicant Pace Medical

K number K011980

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DTE 2000-10-18

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V

Applicant Pace Medical

K number K002204

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DTE 2000-06-27

TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

Applicant Pace Medical

K number K001180

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DTE 1997-08-29

MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM

Applicant Paladin Medical, Inc.

K number K970347

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DTE 1997-07-14

MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL

Applicant Medtronic Vascular

K number K971474

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DTE 1997-07-10

ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

Applicant Biotronik, Inc.

K number K964190

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DTE 1997-06-04

PACE 101H

Applicant Sulzer Oscor, Inc.

K number K970497

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DTE 1996-06-05

ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004

Applicant Zoll Medical Corp

K number K960676

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DTE 1994-11-01

REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601

Applicant Remington Medical, Inc.

K number K940467

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DTE 1994-10-18

POWERCHARGER

Applicant Zoll Medical Corp

K number K934016

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DTE 1994-09-27

MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

Applicant Pace Medical

K number K925143

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DTE 1993-05-19

EXTERNAL DEMAND PACEMAKER

Applicant Oscor Medical Corp.

K number K923621

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DTE 1992-08-14

CPI MODEL 2215

Applicant Seamed Corp.

K number K923398

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DTE 1992-02-07

CHRONOCOR VI MODEL 5012

Applicant Seamed Corp.

K number K915364

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DTE 1991-11-19

MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER

Applicant Pace Medical

K number K913805

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DTE 1991-09-03

CPI MODEL 2215 & SEAMED MODEL 3400

Applicant Seamed Corp.

K number K912507

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DTE 1991-02-25

MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR

Applicant Medtronic Vascular

K number K910237

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DTE 1990-07-19

MODELS 4201, 4231 & 4235 EXTENSION CABLES

Applicant Pace Medical

K number K902679

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DTE 1990-07-17

TRANS-PACE 100

Applicant Synchromed Corp.

K number K900220

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DTE 1990-01-24

MODEL EC4542G MINIATURE

Applicant Pace Medical

K number K896352

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DTE 1989-06-20

MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE

Applicant Medtronic Vascular

K number K893633

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DTE 1988-11-09

SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY

Applicant Seamed Corp.

K number K883930

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DTE 1987-07-31

SEAMED MODEL 3200

Applicant Seamed Corp.

K number K872551

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DTE 1987-06-10

MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543

Applicant Pace Medical

K number K871915

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DTE 1987-03-11

ERA-20

Applicant Biotronik Sales, Inc.

K number K853194

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DTE 1987-03-03

MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER

Applicant Pace Medical

K number K870323

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DTE 1986-12-10

SEA MED MODEL 6000

Applicant Seamed Corp.

K number K863903

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DTE 1986-01-16

SEAMED MODEL 4000

Applicant Seamed Corp.

K number K854648

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DTE 1985-07-16

CHRONOCOR V EXTERNAL PACER, MODEL 297A

Applicant Seamed Corp.

K number K850822

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DTE 1985-02-01

SEAMED MODEL 6000

Applicant Seamed Corp.

K number K843807

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DTE 1985-02-01

SEAMED 4000

Applicant Seamed Corp.

K number K843777

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DTE 1983-12-16

EXTERNAL PULSE GENERATOR FOR TEMP. STIM

Applicant Oscor, Inc.

K number K831768

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DTE 1983-08-31

RAPID ATRIAL PACER

Applicant Seamed Corp.

K number K831381

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DTE 1982-12-15

SEA MED MODEL 880

Applicant Seamed Corp.

K number K823048

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DTE 1982-07-06

EXTERNAL PULSE GENERATOR - EV4542

Applicant American Pacemaker Corp.

K number K821791

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DTE 1982-06-03

SEAMED, #540 - SIEMENS, #146F TELECTRO

Applicant Seamed Corp.

K number K820570

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DTE 1981-07-01

STERILE PACKAGING

Applicant Telectronics, Inc.

K number K811092

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DTE 1981-04-01

SIEMENS MODEL 146-146A EXTERNAL PULSE G

Applicant Cynergy

K number K810566

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DTE 1981-02-23

PACING SYSTEM ANALYZER

Applicant Medtronic Vascular

K number K803313

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DTE 1980-11-19

CHRONOCOR IV MODEL 250

Applicant Cordis Corp.

K number K802221

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DTE 1980-10-31

COMPUPACE, 524-01 PACER SYSTEM COMPUTER

Applicant Intermedics, Inc.

K number K801055

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DTE 1980-10-23

EXTERNAL, TEMP. PORTABLE CARDIAC GENER

Applicant Telectronics, Inc.

K number K801953

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DTE 1980-09-16

CYNERGY MODEL 184

Applicant Cynergy

K number K801596

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DTE 1980-01-31

CYNERGY MODEL 182

Applicant Cynergy

K number K792536

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DTE 1980-01-29

PACEMAKER ELECTRODE INSERTER AIDE

Applicant Telectronics, Inc.

K number K800088

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DTE 1979-11-30

PACESETTER MODEL 350

Applicant Cynergy

K number K792223

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DTE 1978-12-29

MEDTRONIC MODEL 546

Applicant Medtronic Vascular

K number K782108

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DTE 1978-12-11

PULSE GENERATOR, MODEL 240, EXTERNAL

Applicant Intermedics, Inc.

K number K781327

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