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 1986-09-19

MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862054

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DTB 1986-09-19

MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862053

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DTB 1986-08-28

OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH

Applicant Oscor Medical Corp.

K number K861493

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DTB 1986-08-08

MODIFIED OSCOR PY PACING LEADS

Applicant Oscor Medical Corp.

K number K862330

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DTB 1986-08-05

CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR

Applicant Cordis Corp.

K number K851064

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DTB 1986-08-05

CORDIS ANCOR ACTIVE FIXATION LEAD

Applicant Cordis Corp.

K number K832422

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DTB 1986-07-18

IMPLANTABLE ELECTRODE LEAD, MODEL 030-436

Applicant Telectronics, Inc.

K number K861767

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DTB 1986-07-10

MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS

Applicant Medtronic Vascular

K number K862443

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DTB 1986-07-10

MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862259

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DTB 1986-07-10

MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862258

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DTB 1986-07-10

MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862257

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DTB 1986-07-03

MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862052

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DTB 1986-07-02

MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K862276

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DTB 1986-06-26

CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD

Applicant Cordis Corp.

K number K860846

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DTB 1986-06-24

S80 IMPLANTABLE CARDIAC PACING LEAD

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K854963

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DTB 1986-06-13

MODEL 492-02 ENDOCARDIAL PACING LEAD

Applicant Intermedics, Inc.

K number K860548

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DTB 1986-06-13

MODEL 486-02 ENDOCARDIAL PACING LEAD

Applicant Intermedics, Inc.

K number K860547

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DTB 1986-06-06

ENDOCARDIAL CARBON-TIP LEAD

Applicant Pacesetter Systems

K number K861481

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DTB 1986-05-19

LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS

Applicant Pacesetter Systems

K number K861464

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DTB 1986-05-13

LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO

Applicant Pacesetter Systems

K number K861440

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DTB 1986-05-07

DJP UNIPOLAR

Applicant Biotronik Sales, Inc.

K number K853567

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DTB 1986-05-07

DJ UNIPOLAR

Applicant Biotronik Sales, Inc.

K number K853566

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DTB 1986-04-29

MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER

Applicant Intermedics, Inc.

K number K861176

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DTB 1986-04-23

MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER

Applicant Intermedics, Inc.

K number K861110

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DTB 1986-03-31

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

Applicant Intermedics, Inc.

K number K860986

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DTB 1986-03-31

MODEL 366-19 ADAPTAID ADAPTER SLEEVE

Applicant Intermedics, Inc.

K number K860985

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DTB 1986-03-11

MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K854918

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DTB 1986-03-11

MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K854917

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DTB 1986-02-26

OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE

Applicant Oscor Medical Corp.

K number K854128

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DTB 1986-01-15

STYLET INTRODUCER FUNNEL

Applicant Telectronics, Inc.

K number K854142

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DTB 1986-01-15

DNR UNIPOLAR

Applicant Biotronik Sales, Inc.

K number K853568

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DTB 1986-01-13

MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016

Applicant Medtronic Vascular

K number K854582

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DTB 1986-01-13

POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107

Applicant Cardiac Control Systems, Inc.

K number K853446

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DTB 1986-01-08

NAVIGATOR

Applicant Mainsfield Scientific, Inc.

K number K853747

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DTB 1985-12-09

POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD

Applicant Intermedics, Inc.

K number K854069

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DTB 1985-12-04

PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD

Applicant Pacesetter Systems

K number K854405

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DTB 1985-12-04

PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD

Applicant Pacesetter Systems

K number K854220

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DTB 1985-12-04

POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD

Applicant Intermedics, Inc.

K number K854071

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DTB 1985-12-04

EXPLORER

Applicant Mansfield Scientific, Inc.

K number K853850

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DTB 1985-12-04

POLYFLEX IMPLANTABLE PACING LEAD-476-07

Applicant Intermedics, Inc.

K number K853521

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DTB 1985-12-04

LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08

Applicant Intermedics, Inc.

K number K853517

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DTB 1985-12-04

MEDTRONIC MODEL 5062

Applicant Medtronic Vascular

K number K853398

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DTB 1985-12-04

CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA

Applicant Cardiac Control Systems, Inc.

K number K853294

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DTB 1985-12-04

IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A

Applicant Telectronics, Inc.

K number K852710

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DTB 1985-12-03

PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI

Applicant Pacesetter Systems

K number K853914

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DTB 1985-11-05

LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06

Applicant Intermedics, Inc.

K number K853518

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DTB 1985-10-24

LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03

Applicant Intermedics, Inc.

K number K853519

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DTB 1985-10-08

LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD

Applicant Intermedics, Inc.

K number K853520

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DTB 1985-10-01

MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K853411

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DTB 1985-10-01

IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A

Applicant Telectronics, Inc.

K number K852708

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DTB 1985-09-17

SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407

Applicant Telectronics, Inc.

K number K853223

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DTB 1985-09-17

SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402

Applicant Telectronics, Inc.

K number K853222

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DTB 1985-09-17

SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401

Applicant Telectronics, Inc.

K number K853221

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DTB 1985-09-17

IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A

Applicant Telectronics, Inc.

K number K852709

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DTB 1985-09-17

ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP

Applicant Diag Corp.

K number K852446

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DTB 1985-09-16

IMPLANTABLE ELECTRODE LEAD, MODEL 030-400

Applicant Telectronics, Inc.

K number K852972

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DTB 1985-09-15

TEMPORARY PACEMAKER GROUND WIRE

Applicant Scholten Surgical Instruments, Inc.

K number K852119

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DTB 1985-08-29

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860

Applicant Ela Medical, Inc.

K number K851731

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DTB 1985-07-29

SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281

Applicant Telectronics, Inc.

K number K852915

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DTB 1985-07-11

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE

Applicant Telectronics, Inc.

K number K851461

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DTB 1985-04-19

OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE

Applicant Oscor Medical Corp.

K number K850623

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DTB 1985-04-11

IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH

Applicant Telectronics, Inc.

K number K851296

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DTB 1985-04-10

IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET

Applicant Telectronics, Inc.

K number K851297

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DTB 1985-04-10

IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH

Applicant Telectronics, Inc.

K number K851295

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DTB 1985-04-10

IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH

Applicant Telectronics, Inc.

K number K851294

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DTB 1985-04-10

ELECATH TORKFLOAT PACING PROBE

Applicant Electro-Catheter Corp.

K number K850065

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DTB 1985-04-03

INTERMEDICS POLYFLEX PACING LEAD #480-01

Applicant Intermedics, Inc.

K number K820267

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DTB 1985-04-03

MODEL 492-01 PACEMAKER LEAD

Applicant Intermedics, Inc.

K number K813136

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DTB 1985-04-03

MODEL 486-01 PACEMAKER LEAD

Applicant Intermedics, Inc.

K number K813135

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DTB 1985-04-03

POLY FLEX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K802294

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DTB 1985-03-28

MODEL 473-03 PACING LEAD

Applicant Intermedics, Inc.

K number K844272

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DTB 1985-03-28

MODEL 479-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844271

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DTB 1985-03-28

MODEL 480-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844270

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DTB 1985-03-28

MODEL 483-02 PACING LEAD

Applicant Intermedics, Inc.

K number K844269

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DTB 1985-03-28

MODEL 483-03 PACING LEAD

Applicant Intermedics, Inc.

K number K844268

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DTB 1985-03-28

MODEL 483-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844267

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DTB 1985-03-28

MODEL 492-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844266

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DTB 1985-03-28

MODEL 495-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844265

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DTB 1985-03-28

MODEL 493-03 PACING LEAD

Applicant Intermedics, Inc.

K number K844264

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DTB 1985-03-28

MODEL 493-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844263

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DTB 1985-03-28

MODEL 483-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844262

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DTB 1985-03-28

MODEL 490-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844261

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DTB 1985-03-28

MODEL 476-03 PACING LEAD

Applicant Intermedics, Inc.

K number K844260

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DTB 1985-03-28

MODEL 486-01 PACING LEAD

Applicant Intermedics, Inc.

K number K844259

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DTB 1985-03-27

CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS

Applicant Cordis Corp.

K number K844970

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DTB 1985-01-18

MODELS 4012/4512 TRANSVENOUS TINED-

Applicant Medtronic Vascular

K number K842032

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DTB 1985-01-18

TRANSVENOUS TINED VENTRICULAR/ATRIAL

Applicant Medtronic Vascular

K number K842031

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DTB 1985-01-10

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

Applicant Medtronic Vascular

K number K844959

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DTB 1985-01-08

MEDTRONIC 6957J

Applicant Medtronic Vascular

K number K843707

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DTB 1985-01-02

TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA

Applicant Mansfield Scientific, Inc.

K number K844752

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DTB 1984-12-27

MEDTRONIC 6957

Applicant Medtronic Vascular

K number K843706

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DTB 1984-12-27

CORDIS ENCOR ATRIAL LEAD

Applicant Cordis Corp.

K number K811259

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DTB 1984-09-24

LIFELINE TLE 484-02

Applicant Intermedics, Inc.

K number K843394

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DTB 1984-09-24

LIFELINE TLE 476-04

Applicant Intermedics, Inc.

K number K843393

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DTB 1984-09-24

ELECTRODE PACEMAKER, PERM & TEMP

Applicant Vitatron Medical BV

K number K840668

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DTB 1984-03-12

PACING ELECTRODE

Applicant Pacesetter Systems

K number K834431

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DTB 1984-02-04

CCS MODEL AV-102 IMPLANTABLE A-V DATA

Applicant Cardiac Control Systems, Inc.

K number K834342

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DTB 1984-01-30

ELECTRODE LEAD CONSTRUCTION

Applicant Telectronics, Inc.

K number K834533

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DTB 1983-12-01

ENDOCARDIAL SCREW-IN LEAD 859 & 861

Applicant Pacesetter Systems

K number K833824

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DTB 1983-10-20

BIOTRONIK DFH UNIPOLAR PE-60/4-DFH

Applicant Biotronik Sales, Inc.

K number K833106

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