Electrode, Pacemaker, Temporary

FDA product code LDF · 127 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3680
Review panel: CV
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1978-12-04 – 2026-07-30

LDF 2026-07-30

Sync AV II Temporary Pacing Catheter

Applicant Swift Sync, Inc.

K number K252042

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LDF 2025-06-15

Bioptimal Bipolar Pacing Catheter

Applicant Bioptimal International Pte. , Ltd.

K number K242863

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LDF 2025-05-15

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)

Applicant C.R. Bard, Inc.

K number K251186

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LDF 2025-01-31

Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

Applicant C.R. Bard, Inc.

K number K241334

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LDF 2025-01-23

Rotatable Connector (5944RL)

Applicant Shenzhen Launch Electrical Co., Ltd.

K number K241199

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LDF 2025-01-17

Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)

Applicant Medtronic, Inc.

K number K242705

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LDF 2024-04-26

TME Temporary Myocardial Electrode

Applicant Osypka AG

K number K232261

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LDF 2019-08-08

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K number K190716

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LDF 2018-08-02

Temporary Cardiac Pacing Wire

Applicant ETHICON, Inc.

K number K173923

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LDF 2017-05-25

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K number K171253

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LDF 2016-11-22

Pacel Flow Directed Pacing Catheter

Applicant St Jude Medical

K number K161873

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LDF 2016-10-25

Tempo Temporary Pacing Lead

Applicant Biotrace Medical, Inc.

K number K160260

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LDF 2016-08-19

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K number K161249

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LDF 2008-01-22

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)

Applicant Oscor, Inc.

K number K072770

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LDF 2004-09-07

MODEL 6416 TEMPORARY PACING LEAD SYSTEM

Applicant Medtronic Vascular

K number K042190

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LDF 2004-09-02

DETECT SURGICAL PACING AND MAPPING TOOL

Applicant Medtronic Vascular

K number K040812

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LDF 2004-07-12

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

Applicant European Custom Manufacturing BV

K number K033858

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LDF 2003-11-20

TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE

Applicant Peter M. Rothenberg, M.D.

K number K032613

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LDF 2003-06-11

DISPOSABLE TEMPORARY PACING WIRE

Applicant River Medical, Inc.

K number K023174

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LDF 2003-04-22

STEELEX ELECTRODE SET

Applicant Aesculap, Inc.

K number K030556

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LDF 2001-08-21

WECK CARDIAC PACING WIRES

Applicant Weck Closure Systems

K number K011660

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LDF 2001-08-14

MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD

Applicant Medtronic Vascular

K number K012460

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LDF 2001-08-14

MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE

Applicant Medtronic Vascular

K number K012459

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LDF 2001-08-14

MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

Applicant Medtronic Vascular

K number K012458

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LDF 2001-08-14

MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

Applicant Medtronic Vascular

K number K012454

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LDF 2001-08-14

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD

Applicant Medtronic Vascular

K number K012452

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LDF 2001-02-01

ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER

Applicant Zcv ,Inc.

K number K010099

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LDF 2001-01-08

ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER

Applicant Zcv ,Inc.

K number K002603

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LDF 2000-12-07

ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3

Applicant Zcv ,Inc.

K number K002481

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LDF 2000-11-09

ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3

Applicant Zynergy Cardiovascular, Inc.

K number K002687

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LDF 1998-05-26

MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD

Applicant Medtronic Vascular

K number K973360

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LDF 1998-04-10

TEMPORARY CARDIAC PACING WIRE

Applicant ETHICON, Inc.

K number K980503

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LDF 1997-12-29

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610

Applicant Cardiac Control Systems, Inc.

K number K971775

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LDF 1997-11-18

SAFPACE SYSTEM

Applicant B.Braun Medical, Inc.

K number K955829

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LDF 1997-10-15

HARMAC TEMPORARY PACING CATHETER WITH BALLOON

Applicant Harmac Medical Products, Inc.

K number K962833

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LDF 1997-08-14

HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET

Applicant Harmac Medical Products, Inc.

K number K963073

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LDF 1997-07-23

INTRODUCER SHEATH AND DILATOR

Applicant Boston Scientific Corp

K number K971165

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LDF 1997-07-22

MODEL 6495 BIPOLAR TEMPORARY PACING LEAD

Applicant Medtronic Vascular

K number K963898

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LDF 1996-11-13

UNIPOLAR IPG GROUND CABLE, MODEL 5473

Applicant Medtronic Vascular

K number K961520

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LDF 1996-10-17

ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER

Applicant Arrow Intl., Inc.

K number K960479

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LDF 1996-10-11

USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING

Applicant C.R. Bard, Inc.

K number K955712

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LDF 1996-09-17

RV PACING LEAD

Applicant Abbott Laboratories

K number K962467

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LDF 1996-03-15

FLEXON TEMPORARY CARDIAC PACER LEAD

Applicant Davis & Geck, Inc.

K number K955722

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LDF 1995-12-13

UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494

Applicant Medtronic Vascular

K number K954809

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LDF 1995-07-27

MULTIPACE

Applicant Electro-Catheter Corp.

K number K934785

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LDF 1995-07-14

UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492

Applicant Medtronic Blood Systems, Inc.

K number K944966

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LDF 1995-07-14

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

Applicant Medtronic Blood Systems, Inc.

K number K944957

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LDF 1995-07-14

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491

Applicant The Heart Valve Div. Medtronic Cardiovascular Surg

K number K944956

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LDF 1995-02-24

SILICORE SEMI-FLOATER

Applicant Electro-Catheter Corp.

K number K934787

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LDF 1994-01-28

BIPOLAR BALLOON PACING CATHETER BY J-LLOYD

Applicant J-Lloyd Medical, Inc.

K number K930069

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LDF 1993-10-21

ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD

Applicant Angemed, Inc.

K number K924388

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LDF 1993-08-25

ANGEMED 5000 LEAD ADAPTER

Applicant Angemed, Inc.

K number K924390

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LDF 1992-11-23

UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493

Applicant The Heart Valve Div. Medtronic Cardiovascular Surg

K number K922269

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LDF 1992-11-23

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491

Applicant Medtronic Vascular

K number K922268

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LDF 1992-11-23

UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492

Applicant Medtronic Vascular

K number K922182

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LDF 1992-10-19

MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES

Applicant Medtronic Vascular

K number K923407

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LDF 1992-01-27

PACEL(TM) FLOW DIRECTED PACING CATHETER

Applicant Daig Corp.

K number K914185

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LDF 1991-12-27

XEMEX TEMPORARY PACING CATHETER A MODIFIED

Applicant Zeon Medical Corp.

K number K913521

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LDF 1991-05-16

XEMEX TEMPORARY PACING CATHETER A

Applicant Zeon Medical Corp.

K number K904868

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LDF 1990-10-16

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491

Applicant Medtronic Vascular

K number K902342

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LDF 1990-04-19

E-CLIP

Applicant Joel Cohen & Esther R. Cohen

K number K900982

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LDF 1989-12-07

UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490

Applicant Medtronic Vascular

K number K895789

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LDF 1989-08-25

MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE

Applicant Pace Medical

K number K890988

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LDF 1989-06-20

DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER

Applicant Daig Corp.

K number K890794

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LDF 1989-03-22

TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1

Applicant Oscor Medical Corp.

K number K884866

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LDF 1988-09-06

BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER

Applicant C.R. Bard, Inc.

K number K882330

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LDF 1988-07-12

HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK

Applicant Cordis Leads, Inc.

K number K882045

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LDF 1988-05-19

EXTERNAL PACEMAKER WIRE DRESSING CHANGE

Applicant Neal & Assoc., Inc.

K number K881356

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LDF 1988-02-12

DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE

Applicant Daig Corp.

K number K875059

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LDF 1987-12-23

WIRE DRESSING

Applicant Slocum and Neal, Inc.

K number K874310

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LDF 1987-12-03

TEMPORARY PACEMAKER ELECTRODE

Applicant Oscor Medical Corp.

K number K872972

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LDF 1987-11-03

DEKNATEL TEMPORARY CARDIAC PACING WIRE

Applicant Deknatel, Inc.

K number K873728

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LDF 1987-10-07

SUTURELESS TEMPORARY EPICARDIAL PACING LEAD

Applicant Symbion, Inc.

K number K873474

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LDF 1987-10-02

ADULT WALKING HEEL PRODUCT NO. 4183-130

Applicant Martin Medical

K number K873716

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LDF 1987-09-25

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

Applicant Medtronic Vascular

K number K862970

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LDF 1987-03-06

V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540

Applicant Spectramed, Inc.

K number K864507

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LDF 1986-06-27

TB SERIES BIPOLAR PACING LEADS

Applicant Oscor Medical Corp.

K number K861403

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LDF 1986-05-05

SYNCARE TEMPORARY CARDIAC PACING WIRE

Applicant Gyneco, Inc.

K number K861409

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LDF 1986-02-26

FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT

Applicant Davis & Geck, Inc.

K number K855139

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LDF 1985-10-11

MEDTRONIC MODEL 6405

Applicant Medtronic Vascular

K number K853818

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LDF 1985-09-16

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE

Applicant Mansfield Scientific, Inc.

K number K852797

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LDF 1985-09-16

115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD

Applicant C.R. Bard, Inc.

K number K852513

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LDF 1985-09-16

CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA

Applicant Cordis Corp.

K number K851913

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LDF 1985-08-29

NUMED TEMP. STYLET PACING PAROBE 1318694

Applicant NuMED, Inc.

K number K851845

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LDF 1985-04-19

NUMED BALLOON PACING CATHETER

Applicant NuMED, Inc.

K number K851246

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LDF 1985-04-10

OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR

Applicant Oscor Medical Corp.

K number K850622

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LDF 1985-03-27

ELECATH OPEN TIP BIPOLAR PACING CATHETER

Applicant Electro-Catheter Corp.

K number K850324

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LDF 1985-01-14

NUMED BALLOON PACING CATHETER

Applicant NuMED, Inc.

K number K843290

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LDF 1984-12-27

ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH

Applicant Electro-Catheter Corp.

K number K844003

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LDF 1984-10-18

ELECTRODE CATHETER, ORTHOGONAL TYPE

Applicant Webster Laboratories, Inc.

K number K841802

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LDF 1984-09-04

CRITIKON HEPARIN-COATED CARDIOVASCULAR

Applicant Critikon Company, LLC

K number K843141

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LDF 1984-04-24

LUMELEC ELECTRODE CATHETER

Applicant Cordis Corp.

K number K834416

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LDF 1984-02-04

ELECATH HEPARIN COATED TEMP. PACING

Applicant Electro-Catheter Corp.

K number K840109

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LDF 1983-10-20

MULTIPOLAR TEMPORARY CARDIAC

Applicant Oscor, Inc.

K number K831804

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LDF 1983-10-20

TEMP. CARDIAC PACING WIRE TME 60/61/65

Applicant Oscor, Inc.

K number K831695

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LDF 1983-10-19

ELECATH PACEWEDGE DUAL PRESS. BIPOLAR

Applicant Electro-Catheter Corp.

K number K832850

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LDF 1983-10-19

EPCOR MULTIELECTRODE TEMP. PERVENOUS

Applicant Cordis Corp.

K number K832561

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LDF 1983-07-26

TEMP. BIPOLAR EPICARDIAL LEAD

Applicant Cordic Corp.

K number K831645

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LDF 1983-04-18

TEMP. PACING LEAD, BIPOLAR #TH60, 90/110

Applicant Oscor, Inc.

K number K830772

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LDF 1983-02-18

USCI TEMP. ATRIO-VENTRICULAR ELECTRODE

Applicant C.R. Bard, Inc.

K number K830094

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