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 1983-10-20

BIOTRONIK N, BIPOLAR PEB-60/4-N

Applicant Biotronik Sales, Inc.

K number K833099

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DTB 1983-10-20

PERMANTHANE #866 BIPOLAR COAXIAL

Applicant Pacesetter Systems

K number K832987

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DTB 1983-10-20

IMPLANTABLE ENDOCARDIAL PACING LEADS

Applicant Oscor, Inc.

K number K831997

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DTB 1983-10-19

BIOTRONIK I-UNIPOLAR PE-60/2-13

Applicant Biotronik Sales, Inc.

K number K833108

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DTB 1983-10-19

BIOTRONIK D2K UNIPOLAR PE-60/4

Applicant Biotronik Sales, Inc.

K number K833104

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DTB 1983-10-19

BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC

Applicant Biotronik Sales, Inc.

K number K833101

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DTB 1983-10-19

BIOTRONIK DN UNIPOLAR PE-60/4-DN &

Applicant Biotronik Sales, Inc.

K number K833098

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DTB 1983-08-12

LIFELINE PACING LEADS #471-07 &09

Applicant Intermedics, Inc.

K number K832409

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DTB 1983-08-12

MODEL F UNIPOLAR ENDOCARDIAL LEAD-

Applicant Cook Pacemaker Corp.

K number K832255

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DTB 1983-08-12

UNIPOLAR-E ENDOCARDIAL TINED LEAD

Applicant Cook Pacemaker Corp.

K number K832245

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DTB 1983-08-12

ELECTRODE LEADS 030-267 & 030-268

Applicant Telectronics, Inc.

K number K832110

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DTB 1983-07-26

MEDTRONIC MODELS 4012 & 4512

Applicant Medtronic Vascular

K number K832099

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DTB 1983-07-26

IMPLANTABLE CARDIAC PACING LEADS

Applicant Oscor, Inc.

K number K831767

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DTB 1983-06-30

CCS MODEL SJ-103 IMPLANTABLE ATRIAL

Applicant Cardiac Control Systems, Inc.

K number K831529

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DTB 1983-06-08

UNIPOLAR ATRIAL J PACING LEAD MODEL 869

Applicant Pacesetter Systems

K number K831436

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DTB 1983-06-08

VENTRICULAR PACING LEADS MODELS 865/867

Applicant Pacesetter Systems

K number K831435

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DTB 1983-05-25

TELECTRONICS #030-253 BIFURCATED

Applicant William C. Nealon

K number K831303

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DTB 1983-05-09

POROUS TIP ENDOCARDIAL LEAD

Applicant Daig Corp.

K number K830743

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DTB 1983-04-30

MODEL MF..D & MX..D PACEMAKER LEADS

Applicant Oscor, Inc.

K number K823898

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DTB 1983-04-30

MODEL SF. D&SX.D PACEMAKER LEADS

Applicant Oscor, Inc.

K number K823897

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DTB 1983-04-30

MODEL FF..D & FX..D PACEMAKER LEADS

Applicant Dr. Ing. P. Osypka, GmbH

K number K823896

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DTB 1983-04-30

MODEL RF. D&RX..D PACEMAKER LEADS

Applicant Oscor, Inc.

K number K823895

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DTB 1983-04-30

MODEL RZ PACEMAKER LEAD VARIOUS

Applicant Dr. Ing. P. Osypka, GmbH

K number K823894

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DTB 1983-04-30

MODEL MZ PACEMAKER LEAD-VARIOUS

Applicant Oscor, Inc.

K number K823893

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DTB 1983-04-30

MODEL SZ PACEMAKER LEAD-VARIOUS

Applicant Dr. Ing. P. Osypka, GmbH

K number K823892

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DTB 1983-04-30

MODEL JY PACEMAKER LEAD - VARIOUS

Applicant Oscor, Inc.

K number K823889

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DTB 1983-04-28

IMPLANTABLE PACING LEAD CCS MODEL SV-101

Applicant Cardiac Control Systems, Inc.

K number K830828

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DTB 1983-04-18

VASCULAR PRODUCTS IMPLANTABLE PACING

Applicant Oscor, Inc.

K number K830950

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DTB 1983-04-18

LIFELINE ENDOCARDIAL PACING LEAD #479-05

Applicant Intermedics, Inc.

K number K830782

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DTB 1983-03-31

MODEL KY PACEMAKER LEAD - VARIOUS

Applicant Oscor, Inc.

K number K823891

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DTB 1983-03-31

MODEL ZY PACEMAKER LEAD-VARIOUS

Applicant Oscor, Inc.

K number K823890

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DTB 1983-03-17

PACING LEAD #PMA F 860

Applicant Ela Medical, Inc.

K number K830457

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DTB 1983-03-16

PACEMAKER ELECTRODE PERM. & TEMP

Applicant Daig Corp.

K number K830464

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DTB 1983-02-28

LIFELINE UNIPOLAR J-LEAD #483-05

Applicant Intermedics, Inc.

K number K830463

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DTB 1983-01-14

LIFELINE -UNIPOLAR LEAD #487-05

Applicant Intermedics, Inc.

K number K823508

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DTB 1983-01-08

ELECTRODE LEAD OF SILICONE ELASTOMETER

Applicant Telectronics, Inc.

K number K823452

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DTB 1982-12-30

ELECTRODE, PACEMAKER, PERMANENT

Applicant Pacesetter Systems

K number K823033

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DTB 1982-12-03

IMPLANTABLE PACING LEAD TINED #3390 &

Applicant Oscor, Inc.

K number K823448

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DTB 1982-12-03

IMPLANTABLE PACING LEAD, TINED #3262 &

Applicant Vascular Products, Inc.

K number K823447

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DTB 1982-12-03

PRODUCTS IMPLANTABLE PACING LEAD,TINED

Applicant Oscor, Inc.

K number K823446

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DTB 1982-11-30

MEDTRONIC MODELS 4011 & 4511

Applicant Medtronic Vascular

K number K822781

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DTB 1982-10-04

COAXIAL BIPOLAR PACING ELECTRODE

Applicant Burditt & Calkins-Siemens-Elema

K number K822239

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DTB 1982-08-06

FASTPASS IMPLANTABLE ENDOCARD. PACING

Applicant Pacesetter Systems

K number K821947

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DTB 1982-08-06

POROUS SURFACED PLATINUM IRIDIUM

Applicant Cordis Corp.

K number K821889

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DTB 1982-08-06

MEDTRONIC #6993

Applicant Medtronic Vascular

K number K820989

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DTB 1982-04-16

IMPLANTIBLE SUTURE SLEEVE

Applicant Intermedics, Inc.

K number K820487

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DTB 1982-04-09

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60

Applicant Siemens Elema AB

K number K820767

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DTB 1982-03-18

STOCKERT CARDIAC PACING ELECTRODES

Applicant Stoeckert Instrumente

K number K812049

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DTB 1982-03-12

PERMANENT & TEMPORARY PACEMAKER ELECTR.

Applicant Diag Corp.

K number K820262

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DTB 1982-02-12

LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.

Applicant Telectronics, Inc.

K number K820121

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DTB 1982-02-04

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD

Applicant Diag Corp.

K number K812905

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DTB 1982-01-28

INTERSEPT CARDIOTOMY RESERVOIR/FILTER

Applicant Extracorporeal Medical Specialities, Inc.

K number K813205

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DTB 1982-01-18

APC IMPLANTABLE PACING LEAD

Applicant American Pacemaker Corp.

K number K812830

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DTB 1982-01-18

APC IMPLANTABLE PACING LEADS

Applicant American Pacemaker Corp.

K number K812807

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DTB 1981-12-10

ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP

Applicant Telectronics, Inc.

K number K813134

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DTB 1981-12-10

POLY-FLEX PACING LEADS

Applicant Intermedics, Inc.

K number K813028

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DTB 1981-11-27

PACEPATH IMPLANT. ENDOCARD. PACING LEAD

Applicant Pacesetter Systems

K number K810286

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DTB 1981-11-27

ELECTRODE, PACEMAKER, PERMANENT

Applicant Pacesetter Systems

K number K810139

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DTB 1981-11-16

INTERMEDICS POLYFLEX-MODEL 483-04 LEAD

Applicant Intermedics, Inc.

K number K812991

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DTB 1981-11-16

INTERMEDICS POLYFLEX-MODEL 483-03 LEAD

Applicant Intermedics, Inc.

K number K812990

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DTB 1981-11-16

INTERMEDICS POLYFLEX-MODEL 493-03 LEAD

Applicant Intermedics, Inc.

K number K812989

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DTB 1981-10-29

MODEL 841 ENDOCARDIAL TINED LEAD

Applicant Pacesetter Systems

K number K812816

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DTB 1981-10-29

MODEL 833 ENDOCARDIAL TINED LEAD

Applicant Pacesetter Systems

K number K812815

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DTB 1981-10-23

MEDTRONIC #4951

Applicant Medtronic Vascular

K number K812599

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DTB 1981-10-13

ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J

Applicant Telectronics, Inc.

K number K811593

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DTB 1981-10-06

INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL

Applicant Intermedics, Inc.

K number K812245

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DTB 1981-10-06

INTERMEDICS POLY FLEX EPICARDIAL SUTURE

Applicant Intermedics, Inc.

K number K812221

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DTB 1981-09-16

PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL

Applicant Diag Corp.

K number K812270

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DTB 1981-08-13

PACEPATH IMPLANTABLE ENDOCARD. PACING LD

Applicant Pacesetter Systems

K number K811200

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DTB 1981-08-07

TYPE FH ENDOCARDIAL LEAD

Applicant Biotronik Sales, Inc.

K number K810494

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DTB 1981-08-03

MODEL A UNIPOLAR ENDOCARDIAL LEAD

Applicant Cook Pacemaker Corp.

K number K811879

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DTB 1981-08-03

MODEL B BIPOLAR ENDOCARDIAL LEAD

Applicant Cook Pacemaker Corp.

K number K811878

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DTB 1981-08-03

MODEL C UNIPOLAR ENDOCARDIAL LEAD

Applicant Cook Pacemaker Corp.

K number K811877

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DTB 1981-08-03

MODEL D BIPOLAR ENDOCARDIAL LEAD

Applicant Cook Pacemaker Corp.

K number K811876

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DTB 1981-07-02

ENDOCARDIAL ELECTRODE

Applicant Vitatron Medical BV

K number K810928

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DTB 1981-07-01

CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL

Applicant Cordis Corp.

K number K811539

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DTB 1981-05-27

INTERMEDICS POLY FLEX ENDOCARDIAL PACING

Applicant Intermedics, Inc.

K number K811106

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DTB 1981-05-15

APC IMPLANTABEL PACING LEAD, MODEL 3264

Applicant American Pacemaker Corp.

K number K810399

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DTB 1981-05-15

APC IMPLANTABLE PACING LEAD, MODEL 3266

Applicant American Pacemaker Corp.

K number K810398

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DTB 1981-05-15

APC IMPLANTABLE PACING LEAD-FLANGE #3260

Applicant American Pacemaker Corp.

K number K810397

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DTB 1981-05-15

APC IMPLANTABLE PACING LEAD, TINED #3262

Applicant American Pacemaker Corp.

K number K810396

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DTB 1981-03-20

TYPE N ENDOCARDIAL LEAD

Applicant Biotronik Sales, Inc.

K number K810493

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DTB 1981-03-20

TYPE YR ENDOCARDIAL LEAD

Applicant Biotronik Sales, Inc.

K number K810492

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DTB 1981-03-20

TYPE YC ENDOCARDIAL LEAD

Applicant Biotronik Sales, Inc.

K number K810491

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DTB 1981-03-13

ELECTRODE, PACEMAKER PERMANENT

Applicant Pacesetter Systems

K number K810582

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DTB 1981-03-13

CORDIS PERVENOUS ATRIAL LEAD

Applicant Cordis Corp.

K number K810432

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DTB 1981-03-13

TEMPORARY MYOCARDIAL PACING LEAD#6400

Applicant Medtronic Vascular

K number K810333

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DTB 1981-02-09

POLY FLEX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K802295

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DTB 1981-02-05

CORDIS MULTIFILAR PERVENOUS VENTRIC. LD

Applicant Cordis Corp.

K number K810202

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DTB 1981-01-16

ENDOCARDIAL LEADS 414S & 515S

Applicant Siemens Elema AB

K number K802816

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DTB 1981-01-16

PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN

Applicant Daig Corp.

K number K802553

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DTB 1981-01-16

PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE

Applicant Daig Corp.

K number K802552

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DTB 1981-01-16

PERMANENT & TEMP. PACEMAKER ELECTRODE

Applicant Daig Corp.

K number K802547

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DTB 1981-01-02

IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS

Applicant Telectronics, Inc.

K number K802413

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DTB 1980-12-22

SIEMENS-ELEMA ENDOCARDIAL LEAD 402S

Applicant Siemens Elema AB

K number K803042

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DTB 1980-12-22

UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC

Applicant Telectronics, Inc.

K number K802968

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DTB 1980-12-01

LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)

Applicant Medtronic Vascular

K number K801284

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DTB 1980-12-01

INTERMEDICS' LIFELINE TLE ENDOCARDIAL

Applicant Intermedics, Inc.

K number K801172

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DTB 1980-11-13

MEDTRONIC MODEL 6958

Applicant Medtronic Vascular

K number K800870

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DTB 1980-10-31

POLYFLEX IMPLANTABLE PACING LEAD

Applicant Intermedics, Inc.

K number K802293

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