Product Code: LDF FDA class 2 21 CFR 870.3680

Electrode, Pacemaker, Temporary

Cardiovascular

A temporary pacemaker electrode is a transvenous or epicardial electrode used in the short-term treatment of cardiac arrhythmias, bradycardia, or heart block by delivering electrical pacing stimuli to the myocardium until a permanent pacemaker can be implanted or the underlying condition resolves. It is classified as FDA Class 2, requiring 510(k) premarket clearance, under 21 CFR 870.3680 in the Cardiovascular specialty. The product code is LDF. This device is designated as life sustaining or life supporting due to its critical cardiac function.

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510(k)s

129

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LDF
Device Class: FDA class 2
Regulation Number: 870.3680
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 129 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242863	Bioptimal Bipolar Pacing Catheter	Jun 15, 2025	Substantially Equivalent	Bioptimal International Pte. , Ltd.
K251186	Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)	May 15, 2025	Substantially Equivalent	C.R. Bard, Inc.
K241334	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,	Jan 31, 2025	Substantially Equivalent	C.R. Bard, Inc.
K241199	Rotatable Connector (5944RL)	Jan 23, 2025	Substantially Equivalent	Shenzhen Launch Electrical Co., Ltd.
K242705	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)	Jan 17, 2025	Substantially Equivalent	Medtronic, Inc.
K232261	TME Temporary Myocardial Electrode	Apr 26, 2024	Substantially Equivalent	Osypka AG
K190716	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	Aug 08, 2019	Substantially Equivalent	Medtronic
K173923	Temporary Cardiac Pacing Wire	Aug 02, 2018	Substantially Equivalent	ETHICON, Inc.
K171253	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	May 25, 2017	Substantially Equivalent	Medtronic
K161873	Pacel Flow Directed Pacing Catheter	Nov 22, 2016	Substantially Equivalent	St Jude Medical
K160260	Tempo Temporary Pacing Lead	Oct 25, 2016	Substantially Equivalent	Biotrace Medical, Inc.
K161249	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead	Aug 19, 2016	Substantially Equivalent	Medtronic
K152784	Pacel Bipolar Pacing Catheters	Oct 22, 2015	Substantially Equivalent	St Jude Medical
K152633	Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe	Oct 15, 2015	Substantially Equivalent	Edwards Lifesciences, LLC
K140972	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING	Jun 06, 2014	Substantially Equivalent	Medtronic, Inc.
K072770	TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)	Jan 22, 2008	Substantially Equivalent	Oscor, Inc.
K042190	MODEL 6416 TEMPORARY PACING LEAD SYSTEM	Sep 07, 2004	Substantially Equivalent	Medtronic Vascular
K040812	DETECT SURGICAL PACING AND MAPPING TOOL	Sep 02, 2004	Substantially Equivalent	Medtronic Vascular
K033858	TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE	Jul 12, 2004	Substantially Equivalent	European Custom Manufacturing BV
K032613	TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE	Nov 20, 2003	Substantially Equivalent	Peter M. Rothenberg, M.D.
K023174	DISPOSABLE TEMPORARY PACING WIRE	Jun 11, 2003	Substantially Equivalent	River Medical, Inc.
K030556	STEELEX ELECTRODE SET	Apr 22, 2003	Substantially Equivalent	Aesculap, Inc.
K011660	WECK CARDIAC PACING WIRES	Aug 21, 2001	Substantially Equivalent	Weck Closure Systems
K012460	MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD	Aug 14, 2001	Substantially Equivalent	Medtronic Vascular
K012459	MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE	Aug 14, 2001	Substantially Equivalent	Medtronic Vascular
K012458	MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD	Aug 14, 2001	Substantially Equivalent	Medtronic Vascular
K012454	MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD	Aug 14, 2001	Substantially Equivalent	Medtronic Vascular
K012452	MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD	Aug 14, 2001	Substantially Equivalent	Medtronic Vascular
K010099	ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER	Feb 01, 2001	Substantially Equivalent	Zcv ,Inc.
K002603	ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER	Jan 08, 2001	Substantially Equivalent	Zcv ,Inc.
K002481	ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3	Dec 07, 2000	Substantially Equivalent	Zcv ,Inc.
K002687	ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3	Nov 09, 2000	Substantially Equivalent	Zynergy Cardiovascular, Inc.
K973360	MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD	May 26, 1998	Substantially Equivalent	Medtronic Vascular
K980503	TEMPORARY CARDIAC PACING WIRE	Apr 10, 1998	Substantially Equivalent	ETHICON, Inc.
K971775	INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610	Dec 29, 1997	Substantially Equivalent	Cardiac Control Systems, Inc.
K955829	SAFPACE SYSTEM	Nov 18, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K962833	HARMAC TEMPORARY PACING CATHETER WITH BALLOON	Oct 15, 1997	Substantially Equivalent	Harmac Medical Products, Inc.
K963073	HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET	Aug 14, 1997	Substantially Equivalent	Harmac Medical Products, Inc.
K971165	INTRODUCER SHEATH AND DILATOR	Jul 23, 1997	Substantially Equivalent	Boston Scientific Corp
K963898	MODEL 6495 BIPOLAR TEMPORARY PACING LEAD	Jul 22, 1997	Substantially Equivalent	Medtronic Vascular
K961520	UNIPOLAR IPG GROUND CABLE, MODEL 5473	Nov 13, 1996	Substantially Equivalent	Medtronic Vascular
K960479	ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER	Oct 17, 1996	Substantially Equivalent	Arrow Intl., Inc.
K955712	USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING	Oct 11, 1996	Substantially Equivalent	C.R. Bard, Inc.
K962467	RV PACING LEAD	Sep 17, 1996	Substantially Equivalent	Abbott Laboratories
K955722	FLEXON TEMPORARY CARDIAC PACER LEAD	Mar 15, 1996	Substantially Equivalent	Davis & Geck, Inc.
K954809	UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494	Dec 13, 1995	Substantially Equivalent	Medtronic Vascular
K934785	MULTIPACE	Jul 27, 1995	Substantially Equivalent	Electro-Catheter Corp.
K944966	UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492	Jul 14, 1995	Substantially Equivalent	Medtronic Blood Systems, Inc.
K944957	TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500	Jul 14, 1995	Substantially Equivalent	Medtronic Blood Systems, Inc.
K944956	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491	Jul 14, 1995	Substantially Equivalent	The Heart Valve Div. Medtronic Cardiovascular Surg
K934787	SILICORE SEMI-FLOATER	Feb 24, 1995	Substantially Equivalent	Electro-Catheter Corp.
K930069	BIPOLAR BALLOON PACING CATHETER BY J-LLOYD	Jan 28, 1994	Substantially Equivalent	J-Lloyd Medical, Inc.
K924388	ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD	Oct 21, 1993	Substantially Equivalent	Angemed, Inc.
K924390	ANGEMED 5000 LEAD ADAPTER	Aug 25, 1993	Substantially Equivalent	Angemed, Inc.
K922269	UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493	Nov 23, 1992	Substantially Equivalent	The Heart Valve Div. Medtronic Cardiovascular Surg
K922268	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491	Nov 23, 1992	Substantially Equivalent	Medtronic Vascular
K922182	UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492	Nov 23, 1992	Substantially Equivalent	Medtronic Vascular
K923407	MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES	Oct 19, 1992	Substantially Equivalent	Medtronic Vascular
K914185	PACEL(TM) FLOW DIRECTED PACING CATHETER	Jan 27, 1992	Substantially Equivalent	Daig Corp.
K913521	XEMEX TEMPORARY PACING CATHETER A MODIFIED	Dec 27, 1991	Substantially Equivalent	Zeon Medical Corp.
K904868	XEMEX TEMPORARY PACING CATHETER A	May 16, 1991	Substantially Equivalent	Zeon Medical Corp.
K902342	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491	Oct 16, 1990	Substantially Equivalent	Medtronic Vascular
K900982	E-CLIP	Apr 19, 1990	Substantially Equivalent	Joel Cohen & Esther R. Cohen
K895789	UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490	Dec 07, 1989	Substantially Equivalent	Medtronic Vascular
K890988	MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE	Aug 25, 1989	Substantially Equivalent	Pace Medical
K890794	DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER	Jun 20, 1989	Substantially Equivalent	Daig Corp.
K884866	TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1	Mar 22, 1989	Substantially Equivalent	Oscor Medical Corp.
K882330	BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER	Sep 06, 1988	Substantially Equivalent	C.R. Bard, Inc.
K882045	HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK	Jul 12, 1988	Substantially Equivalent	Cordis Leads, Inc.
K881356	EXTERNAL PACEMAKER WIRE DRESSING CHANGE	May 19, 1988	Substantially Equivalent	Neal & Assoc., Inc.
K875059	DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE	Feb 12, 1988	Substantially Equivalent	Daig Corp.
K874310	WIRE DRESSING	Dec 23, 1987	Substantially Equivalent	Slocum and Neal, Inc.
K872972	TEMPORARY PACEMAKER ELECTRODE	Dec 03, 1987	Substantially Equivalent	Oscor Medical Corp.
K873728	DEKNATEL TEMPORARY CARDIAC PACING WIRE	Nov 03, 1987	Substantially Equivalent	Deknatel, Inc.
K873474	SUTURELESS TEMPORARY EPICARDIAL PACING LEAD	Oct 07, 1987	Substantially Equivalent	Symbion, Inc.
K873716	ADULT WALKING HEEL PRODUCT NO. 4183-130	Oct 02, 1987	Substantially Equivalent	Martin Medical
K862970	TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500	Sep 25, 1987	Substantially Equivalent	Medtronic Vascular
K864507	V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540	Mar 06, 1987	Substantially Equivalent	Spectramed, Inc.
K861403	TB SERIES BIPOLAR PACING LEADS	Jun 27, 1986	Substantially Equivalent	Oscor Medical Corp.
K861409	SYNCARE TEMPORARY CARDIAC PACING WIRE	May 05, 1986	Substantially Equivalent	Gyneco, Inc.
K855139	FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT	Feb 26, 1986	Substantially Equivalent	Davis & Geck, Inc.
K853818	MEDTRONIC MODEL 6405	Oct 11, 1985	Substantially Equivalent	Medtronic Vascular
K852797	HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE	Sep 16, 1985	Substantially Equivalent	Mansfield Scientific, Inc.
K852513	115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD	Sep 16, 1985	Substantially Equivalent	C.R. Bard, Inc.
K851913	CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA	Sep 16, 1985	Substantially Equivalent	Cordis Corp.
K851845	NUMED TEMP. STYLET PACING PAROBE 1318694	Aug 29, 1985	Substantially Equivalent	NuMED, Inc.
K851246	NUMED BALLOON PACING CATHETER	Apr 19, 1985	Substantially Equivalent	NuMED, Inc.
K850622	OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR	Apr 10, 1985	Substantially Equivalent	Oscor Medical Corp.
K850324	ELECATH OPEN TIP BIPOLAR PACING CATHETER	Mar 27, 1985	Substantially Equivalent	Electro-Catheter Corp.
K843290	NUMED BALLOON PACING CATHETER	Jan 14, 1985	Substantially Equivalent	NuMED, Inc.
K844003	ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH	Dec 27, 1984	Substantially Equivalent	Electro-Catheter Corp.
K841802	ELECTRODE CATHETER, ORTHOGONAL TYPE	Oct 18, 1984	Substantially Equivalent	Webster Laboratories, Inc.
K843141	CRITIKON HEPARIN-COATED CARDIOVASCULAR	Sep 04, 1984	Substantially Equivalent	Critikon Company, LLC
K834416	LUMELEC ELECTRODE CATHETER	Apr 24, 1984	Substantially Equivalent	Cordis Corp.
K840109	ELECATH HEPARIN COATED TEMP. PACING	Feb 04, 1984	Substantially Equivalent	Electro-Catheter Corp.
K831804	MULTIPOLAR TEMPORARY CARDIAC	Oct 20, 1983	Substantially Equivalent	Oscor, Inc.
K831695	TEMP. CARDIAC PACING WIRE TME 60/61/65	Oct 20, 1983	Substantially Equivalent	Oscor, Inc.
K832850	ELECATH PACEWEDGE DUAL PRESS. BIPOLAR	Oct 19, 1983	Substantially Equivalent	Electro-Catheter Corp.
K832561	EPCOR MULTIELECTRODE TEMP. PERVENOUS	Oct 19, 1983	Substantially Equivalent	Cordis Corp.
K831645	TEMP. BIPOLAR EPICARDIAL LEAD	Jul 26, 1983	Substantially Equivalent	Cordic Corp.
K830772	TEMP. PACING LEAD, BIPOLAR #TH60, 90/110	Apr 18, 1983	Substantially Equivalent	Oscor, Inc.
K830094	USCI TEMP. ATRIO-VENTRICULAR ELECTRODE	Feb 18, 1983	Substantially Equivalent	C.R. Bard, Inc.
K822003	BALLOON TEMP. PACING CATHETER	Oct 15, 1982	Substantially Equivalent	Ziehm International, Inc.
K822002	BIPOLAR TEMP. PACING CATHETER W/STYLETET	Oct 15, 1982	Substantially Equivalent	Ziehm International, Inc.
K822155	ETHICON TEMPORARY CARDIAC PACING WIRE	Aug 24, 1982	Substantially Equivalent	ETHICON, Inc.
K821518	MYO/CLIP	Jul 08, 1982	Substantially Equivalent	Alto Development Corp.
K821333	ATRIAL J TEMPORARY PACING ELECTRODESS	Jun 02, 1982	Substantially Equivalent	Medics Instrument Corp.
K820232	TRANSTHORACIC TEMP. PACEMAKER #100TPE	Apr 09, 1982	Substantially Equivalent	Trans Pace, Inc.
K820003	CARDIOVASCULAR TEMP. PACEMAKER ELEC	Mar 26, 1982	Substantially Equivalent	Diag Corp.
K813521	TRANSLUMINAL BIPOLAR PACING PROBE	Mar 15, 1982	Substantially Equivalent	American Edwards Laboratories
K813138	ETHICON* TEMP. CARDIAC PACING WIRE	Dec 10, 1981	Substantially Equivalent	ETHICON, Inc.
K812725	MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD	Nov 16, 1981	Substantially Equivalent	Medtronic Vascular
K812781	TEMPORARY PERVENOUS J-ATRIAL LEAD	Oct 29, 1981	Substantially Equivalent	Cordis Corp.
K812517	CARDIAC PACING ELECTRODES	Oct 13, 1981	Substantially Equivalent	Medics Instrument Corp.
K812307	USCI TRANSTHORACIC TEMP. PACING ELECTROD	Sep 21, 1981	Substantially Equivalent	C.R. Bard, Inc.
K811318	TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880	Jul 20, 1981	Substantially Equivalent	Medtronic Vascular
K803086	MYOWIRE-ATEMPORARY CARDIAC PACING WIRE	Jul 01, 1981	Substantially Equivalent	Craig & Craig, Inc.
K810657	TEMPTRON #'S 6804/6805	Apr 08, 1981	Substantially Equivalent	Medtronic Vascular
K810643	UNIVERSAL PACING ELECTRODE KIT	Apr 08, 1981	Substantially Equivalent	Stanco Medical, Inc.
K810642	ATRIAL-VENTRICULAR PACING ELECTRODE KIT	Apr 08, 1981	Substantially Equivalent	Stanco Medical, Inc.
K810312	ELECATH DUAL MODE TRANSTHORACIC PACING	Mar 04, 1981	Substantially Equivalent	Electro-Catheter Corp.
K810041	CORDIS TEMPORATY CURVED ATRIAL LEAD	Feb 05, 1981	Substantially Equivalent	Cordis Corp.
K803058	SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.	Jan 16, 1981	Substantially Equivalent	American Edwards Laboratories
K801799	ATRIAL/VENTRICULAR SEQENTIAL #080-20000	Jan 02, 1981	Substantially Equivalent	Medical Testing System, Inc.
K802259	TRANSVENOUS PACEMAKER ELECTRODE KIT	Oct 23, 1980	Substantially Equivalent	Stanco Medical, Inc.
K801800	UNIVERSAL TEMP. PACING ELECT. #080-10000	Oct 23, 1980	Substantially Equivalent	Medical Testing System, Inc.
K800298	USCI BIPOLAR BALLON PACING ELECTRODE	Apr 16, 1980	Substantially Equivalent	C.R. Bard, Inc.
K791183	SWAN-GANZ FLOW-DIRECTED CATHETER	Jul 12, 1979	Substantially Equivalent	Edwards Lifesciences, LLC
K781002	TEMPORARY CARDIAC PACING WIRE	Dec 04, 1978	Substantially Equivalent	ETHICON, Inc.