Permanent Pacemaker Electrode

FDA product code DTB · 487 cleared devices

Class 3 Cardiovascular

Regulation: 21 CFR 870.3680
Review panel: CV
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-26 – 2006-07-10

DTB 1980-10-31

PACEPATH MODEL 810

Applicant Pacesetter Systems

K number K801416

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DTB 1980-10-23

IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.

Applicant Telectronics, Inc.

K number K801792

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DTB 1980-10-23

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM

Applicant Pacesetter Systems

K number K801455

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DTB 1980-10-23

PACEPATH MODEL 819

Applicant Pacesetter Systems

K number K801417

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DTB 1980-09-26

MEDTRONIC MODEL 69575

Applicant Medtronic Vascular

K number K800944

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DTB 1980-06-30

PERMANENT & TEMP. PACEMAKER ELECTRODE

Applicant Daig Corp.

K number K800795

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DTB 1980-06-04

LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL

Applicant Intermedics, Inc.

K number K792301

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DTB 1980-06-04

LIFELINE TLE (TRAEBECULAR LODGING ELEC

Applicant Intermedics, Inc.

K number K792300

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DTB 1980-05-30

LEAD, TINED PACING, IMPLANTABLE

Applicant Daig Corp.

K number K800354

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DTB 1980-05-28

RESTERILIZATION OF IMPLANTABLE ELECTRODE

Applicant Telectronics, Inc.

K number K800891

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DTB 1980-05-28

LEAD, SUTURELESS MYOCARDIAL

Applicant Daig Corp.

K number K800355

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DTB 1980-05-28

PACEMAKER, ELECTRODE

Applicant Daig Corp.

K number K800352

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DTB 1980-05-28

PACEMAKER, ELECTRODE, PERM. & TEMP.

Applicant Daig Corp.

K number K800351

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DTB 1980-05-28

ENDOCARD. PACING LEAD STD. LENGTH PL202

Applicant Daig Corp.

K number K800350

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DTB 1980-05-28

ENDOCARD. PACING LEAD LONG LENGTH PL200

Applicant Diag Corp.

K number K800349

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DTB 1980-05-28

UNIPOLAR LEAD CONFIGURATION CONDUCTOR

Applicant Daig Corp.

K number K800348

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DTB 1980-05-28

PERM. INPLANT ENDOCARD. PAC. LEAD

Applicant Daig Corp.

K number K800347

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DTB 1979-12-31

LIFELINE TLE ENDOCARDIAL PACING LEAD,

Applicant Intermedics, Inc.

K number K792604

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DTB 1979-12-13

IMPLANTABLE END. MUSH. TIP LEADS030-224

Applicant Telectronics, Inc.

K number K792321

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DTB 1979-12-05

IMPLANTABLE ENDOCARDIAL TINED ELECTRODE

Applicant Telectronics, Inc.

K number K792387

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DTB 1979-12-05

CARDIAC PACING ELECTRODE

Applicant Medi-Dyne Instruments, Inc.

K number K792379

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DTB 1979-11-13

LIFELINE - ENDOCARDIAL PACING LEAD

Applicant Intermedics, Inc.

K number K792168

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DTB 1979-11-05

CORDIS PERMANENT PERVENOUS CARDIAC LEADS

Applicant Cordis Corp.

K number K791768

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DTB 1979-09-19

MEDTRONIC MODEL 6957

Applicant Medtronic Vascular

K number K791769

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DTB 1979-09-19

IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC

Applicant Oscor, Inc.

K number K791732

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DTB 1979-09-19

VENTRICULAR LEAD, MODEL 6959

Applicant Medtronic Vascular

K number K790143

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DTB 1979-09-12

MODEL 482-01 BIPOLAR COAXIAL PACING LEAD

Applicant Intermedics, Inc.

K number K791378

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DTB 1979-09-12

MODEL 484-01 BIPOLAR COAXIAL PACING LEAD

Applicant Intermedics, Inc.

K number K791377

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DTB 1979-09-07

MEDTRONIC MODELS 69914/699OU

Applicant Medtronic Vascular

K number K791667

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DTB 1979-09-04

MODELS UL-804 AND BL-801 UNIPOLAR LEADS

Applicant Pacesetter Systems

K number K791552

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DTB 1979-07-10

BIFLEX TM TEMPORARY PACING PROBE

Applicant Advanced Medical Concepts, Inc.

K number K790983

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DTB 1979-07-05

MEDTRONIC MODEL 6957

Applicant Medtronic Vascular

K number K790429

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DTB 1979-06-11

MODEL 6971 W/ DBS WIRE

Applicant Medtronic Vascular

K number K790988

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DTB 1979-06-04

LEADS, IMPLANTABLE CARDIAC PACEMAKERS

Applicant Oscor, Inc.

K number K782018

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DTB 1979-06-01

ENDOCARDIAL PACING LEAD, MODEL 476-01

Applicant Intermedics, Inc.

K number K790548

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DTB 1979-05-25

MEDTRONIC MODELS 6907/6901

Applicant Medtronic Vascular

K number K790766

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DTB 1979-04-17

BIPOLAR PERNENOUS VENTRICULAR LEAD

Applicant Cordis Corp.

K number K790344

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DTB 1979-04-16

MEDTRONIC MODEL 6972

Applicant Medtronic Vascular

K number K790462

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DTB 1979-04-03

LEAD MODELS MUM 1260, MUM 1290

Applicant Ela Medical, Inc.

K number K790386

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DTB 1979-03-29

MEDTRONIC MODEL 6971

Applicant Medtronic Vascular

K number K790074

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DTB 1979-02-27

MEDTRONIC TEMPTRON

Applicant Medtronic Vascular

K number K790261

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DTB 1979-02-08

CARDIOTOMY RESERVOIR CR-2000

Applicant Delta Medical Industries

K number K790116

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DTB 1979-02-01

SUTURELESS MUOCARDINE PACING LEADS 471

Applicant Intermedics, Inc.

K number K781570

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DTB 1979-02-01

ENDOCARIDAL PACING LEAD UNIPOLAR 477

Applicant Intermedics, Inc.

K number K781525

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DTB 1979-02-01

LIFELINE PACING LEAD MODEL 467-01

Applicant Intermedics, Inc.

K number K781499

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DTB 1979-02-01

LIFELINE BIPOLAR PACING LEAD MOD. 466-01

Applicant Intermedics, Inc.

K number K781498

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DTB 1979-02-01

LIFELINE PACING LEAD MODEL 465-01

Applicant Intermedics, Inc.

K number K781497

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DTB 1979-01-15

LEAD, SUTURELESS MYOCARDIAL

Applicant Daig Corp.

K number K782087

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DTB 1978-12-21

PACING LEAD MODEL BUS 860, BUS 890

Applicant R.E. Brown Co., Inc.

K number K781624

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DTB 1978-12-15

LEAD, TIMED PACING, IMPLANTABLE

Applicant Daig Corp.

K number K782004

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DTB 1978-12-08

PACING LEAD MODEL MVM 860, MVM 890

Applicant R.E. Brown Co., Inc.

K number K781625

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DTB 1978-12-08

PACING MODELS MUM 860, MUM 890

Applicant R.E. Brown Co., Inc.

K number K781623

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DTB 1978-12-08

PACING LEAD MODELS, MAM 1260 MAM 1290

Applicant R.E. Brown Co., Inc.

K number K781621

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DTB 1978-12-08

PACING LEAD MODELS, MDM 1060, MDM 1090

Applicant R.E. Brown Co., Inc.

K number K781620

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DTB 1978-12-08

PACING LEAD MODELS SA, 350, SAM 500

Applicant R.E. Brown Co., Inc.

K number K781619

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DTB 1978-12-04

ELECTRODES, IMPLANTABLE WITH ADAPTER

Applicant Telectronics, Inc.

K number K781849

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DTB 1978-12-04

ENDOCARDIAL BIPOLAR LEAD

Applicant American Technology, Inc.

K number K781456

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DTB 1978-12-04

UNIPOPLAR ENDOCARDIAL LEADS

Applicant American Technology, Inc.

K number K781326

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DTB 1978-10-27

PACING LEADS MODEL UL-811 AND UL-813

Applicant Pacesetter Systems

K number K781776

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DTB 1978-08-31

PACEMAKER, ELECTRODE, PERMANENT & TEMP.

Applicant Daig Corp.

K number K780246

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DTB 1978-07-28

ENDOCARDIAL ATRIAL PACING LEAD, M. 6994

Applicant Medtronic Vascular

K number K780623

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DTB 1978-07-28

BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902

Applicant Medtronic Vascular

K number K780622

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DTB 1978-07-26

LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED

Applicant Medtronic Vascular

K number K780621

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DTB 1978-06-14

L-12, L-21, AND L-22 ELECTRODES

Applicant Coratomic, Inc.

K number K780569

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DTB 1978-05-19

SUTURELESS MYOCARDIAL PACING LEAD

Applicant Medtronic Vascular

K number K780446

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DTB 1978-02-06

ENDOCARDIAL PACING ELECTRODE

Applicant Coratomic, Inc.

K number K772309

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DTB 1978-01-30

PACEMAKER, PERM. & TEMP., ELECTRODE

Applicant Daig Corp.

K number K772197

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DTB 1978-01-11

RESTERIL. OF IMPLANT. ELECT. & ADAPTER

Applicant Telectronics, Inc.

K number K772331

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DTB 1978-01-11

VENTRICULAR LEADS

Applicant Medtronic Vascular

K number K772203

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DTB 1977-11-28

PACING LEAD MODEL 6991A

Applicant Medtronic Vascular

K number K772104

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DTB 1977-11-21

BIPOLAR LEADS, DISP.

Applicant Medtronic Vascular

K number K772103

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DTB 1977-09-14

ENDOCARD. PACING LEAD-LONG LENGTH PL203

Applicant Daig Corp.

K number K771567

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DTB 1977-09-14

ENDOCAR. PACING LEAD-STD. LENGTH PL202

Applicant Daig Corp.

K number K771566

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DTB 1977-09-14

ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200

Applicant Daig Corp.

K number K771565

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DTB 1977-09-14

ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100

Applicant Daig Corp.

K number K771564

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DTB 1977-08-16

CATHETER, CARDIAC PACING, ENDOCARDIAL

Applicant American Technology, Inc.

K number K771528

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DTB 1977-04-05

UNIPOLAR LEAD CONFIGURATION CONDUCTOR

Applicant Daig Corp.

K number K770468

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DTB 1977-03-28

TEMP. PERVENOUS LEAD W/REMOTE ANODE

Applicant Cordis Corp.

K number K770214

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DTB 1977-03-10

LEAD, HEART, BUTTERFLY CLAMP

Applicant Arco Medical Products Co.

K number K770416

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DTB 1977-02-24

BALL TIP, MODEL #030-188

Applicant Med Telectronics , Ltd.

K number K770285

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DTB 1977-02-24

BALL TIP, MODEL #030-185

Applicant Med Telectronics , Ltd.

K number K770284

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DTB 1977-02-24

WEDGE TIP, SMALL, MODEL #030-194

Applicant Med Telectronics , Ltd.

K number K770283

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DTB 1977-02-24

WEDGE TIP, SMALL, MODEL #030-191

Applicant Med Telectronics , Ltd.

K number K770282

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DTB 1977-02-07

PERM. IMPLANT. ENDOCARDIAL PAC. LEAD

Applicant Daig Corp.

K number K770195

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DTB 1976-12-14

ENDO-LOK L-40 ENDOCARDIAL PACING ELECT.

Applicant Coratomic, Inc.

K number K760714

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DTB 1976-10-15

ELECTRODE, TEMPORARY MYOCARDIAL

Applicant Winn Hirsch & Assoc.

K number K760513

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DTB 1976-08-26

CARDIAC ELECTRODE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K760443

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