Product code LDF

Device name: Electrode, Pacemaker, Temporary
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.3680
Review panel: CV
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242863	Bioptimal Bipolar Pacing Catheter	Bioptimal International Pte. , Ltd.	2025-06-15
K251186	Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)	C.R. Bard, Inc.	2025-05-15
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...	C.R. Bard, Inc.	2025-01-31
K241199	Rotatable Connector (5944RL)	Shenzhen Launch Electrical Co., Ltd.	2025-01-23
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) Str...	Medtronic, Inc.	2025-01-17
K232261	TME Temporary Myocardial Electrode	Osypka AG	2024-04-26
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	Medtronic	2019-08-08
K173923	Temporary Cardiac Pacing Wire	ETHICON, Inc.	2018-08-02
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	Medtronic	2017-05-25
K161873	Pacel Flow Directed Pacing Catheter	St Jude Medical	2016-11-22
K160260	Tempo Temporary Pacing Lead	Biotrace Medical, Inc.	2016-10-25
K161249	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead	Medtronic	2016-08-19
K152784	Pacel Bipolar Pacing Catheters	St Jude Medical	2015-10-22
K152633	Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe	Edwards Lifesciences, LLC	2015-10-15
K140972	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING	Medtronic, Inc.	2014-06-06
K072770	TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)	Oscor, Inc.	2008-01-22
K042190	MODEL 6416 TEMPORARY PACING LEAD SYSTEM	Medtronic Vascular	2004-09-07
K040812	DETECT SURGICAL PACING AND MAPPING TOOL	Medtronic Vascular	2004-09-02
K033858	TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE	European Custom Manufacturing BV	2004-07-12
K032613	TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE	Peter M. Rothenberg, M.D.	2003-11-20
K023174	DISPOSABLE TEMPORARY PACING WIRE	River Medical, Inc.	2003-06-11
K030556	STEELEX ELECTRODE SET	Aesculap, Inc.	2003-04-22
K011660	WECK CARDIAC PACING WIRES	Weck Closure Systems	2001-08-21
K012454	MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD	Medtronic Vascular	2001-08-14
K012459	MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE	Medtronic Vascular	2001-08-14
K012452	MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD	Medtronic Vascular	2001-08-14
K012460	MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD	Medtronic Vascular	2001-08-14
K012458	MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD	Medtronic Vascular	2001-08-14
K010099	ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER	Zcv ,Inc.	2001-02-01
K002603	ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER	Zcv ,Inc.	2001-01-08

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850056280006	SoloPace Fusion Ground Pad	SOLO PACE INC.	2026-02-05
00836559001911	Temporary Myocardial Heartwire	Oscor Inc.	2025-09-15
00836559001904	Temporary Myocardial Heartwire	Oscor Inc.	2025-09-15
06947437902535	Medtronic	SHENZHEN LAUNCH ELECTRICAL CO., LTD	2025-02-08
30705031050864	ETHICON	ETHICON, LLC	2015-09-24
10705031050877	ETHICON	ETHICON, LLC	2015-09-01
00801741011351	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011535	N/A	C. R. Bard, Inc.	2015-06-29
00801741011511	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011504	GOETZ™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011498	GOETZ™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011481	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011474	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011375	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011368	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011191	N/A	C. R. Bard, Inc.	2015-06-29
00801741011344	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011337	GOETZ™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011320	GOETZ™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011313	GOETZ™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011306	GOETZ™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011290	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011283	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011276	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011269	NBIH™ Temporary Pacing Electrode Catheter	C. R. Bard, Inc.	2015-06-29
00801741011245	N/A	C. R. Bard, Inc.	2015-06-29
00801741011238	N/A	C. R. Bard, Inc.	2015-06-29
00801741011221	N/A	C. R. Bard, Inc.	2015-06-29
00801741011214	N/A	C. R. Bard, Inc.	2015-06-29
00801741011207	N/A	C. R. Bard, Inc.	2015-06-29

Product code LDF

Related 510(k) Records#

Related GUDID Devices#