LDF · Electrode, Pacemaker, Temporary
Cardiovascular · 21 CFR 870.3680 · Class 2
Overview
| Product Code | LDF |
|---|---|
| Device Name | Electrode, Pacemaker, Temporary |
| Regulation | 21 CFR 870.3680 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
Classification Rationale
Temporary pacemaker electrode: Class II (performance standards). Permanent pacemaker electrode: Class III (premarket approval).
Recent Cleared Devices (20 of 128)
Showing 20 most recent of 128 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242863 | Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. | Jun 15, 2025 | SESE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. | May 15, 2025 | SESE |
| 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, | C.R. Bard, Inc. | Jan 31, 2025 | SESE |
| K241199 | Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd. | Jan 23, 2025 | SESE |
| 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) | Medtronic, Inc. | Jan 17, 2025 | SESE |
| K232261 | TME Temporary Myocardial Electrode | Osypka AG | Apr 26, 2024 | SESE |
| 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 | Aug 8, 2019 | SESE |
| K173923 | Temporary Cardiac Pacing Wire | ETHICON, Inc. | Aug 2, 2018 | SESE |
| 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 | May 25, 2017 | SESE |
| K161873 | Pacel Flow Directed Pacing Catheter | St Jude Medical | Nov 22, 2016 | SESE |
| K160260 | Tempo Temporary Pacing Lead | Biotrace Medical, Inc. | Oct 25, 2016 | SESE |
| K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | Medtronic | Aug 19, 2016 | SESE |
| K152784 | Pacel Bipolar Pacing Catheters | St Jude Medical | Oct 22, 2015 | SESE |
| K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe | Edwards Lifesciences, LLC | Oct 15, 2015 | SESE |
| K140972 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING | Medtronic, Inc. | Jun 6, 2014 | SESE |
| K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | Oscor, Inc. | Jan 22, 2008 | SESE |
| K042190 | MODEL 6416 TEMPORARY PACING LEAD SYSTEM | Medtronic Vascular | Sep 7, 2004 | SESE |
| K040812 | DETECT SURGICAL PACING AND MAPPING TOOL | Medtronic Vascular | Sep 2, 2004 | SESE |
| K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | European Custom Manufacturing BV | Jul 12, 2004 | SESE |
| K032613 | TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE | Peter M. Rothenberg, M.D. | Nov 20, 2003 | SESE |
Top Applicants
- Medtronic Vascular — 21 clearances
- C.R. Bard, Inc. — 8 clearances
- Electro-Catheter Corp. — 7 clearances
- Cordis Corp. — 5 clearances
- Oscor, Inc. — 4 clearances
