FDA 510(k) Applications for Medical Device Product Code "LDF"
(Electrode, Pacemaker, Temporary)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K962467 | ABBOTT LABORATORIES | RV PACING LEAD | 09/17/1996 |
| K030556 | AESCULAP, INC. | STEELEX ELECTRODE SET | 04/22/2003 |
| K960479 | ARROW INTL., INC. | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER | 10/17/1996 |
| K955829 | B. BRAUN MEDICAL, INC. | SAFPACE SYSTEM | 11/18/1997 |
| K160260 | BIO TRACE MEDICAL, INC. | Tempo Temporary Pacing Lead | 10/25/2016 |
| K242863 | Bioptimal International Pte. Ltd. | Bioptimal Bipolar Pacing Catheter | 06/15/2025 |
| K971165 | BOSTON SCIENTIFIC CORP. | INTRODUCER SHEATH AND DILATOR | 07/23/1997 |
| K251186 | C. R. Bard, Inc. | Bard« Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | 05/15/2025 |
| K241334 | C. R. Bard, Inc. | 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 | 01/31/2025 |
| K955712 | C.R. BARD, INC. | USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING | 10/11/1996 |
| K971775 | CARDIAC CONTROL SYSTEMS, INC. | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 | 12/29/1997 |
| K955722 | DAVIS & GECK, INC. | FLEXON TEMPORARY CARDIAC PACER LEAD | 03/15/1996 |
| K152633 | EDWARDS LIFESCIENCES, LLC | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe | 10/15/2015 |
| K980503 | ETHICON, INC. | TEMPORARY CARDIAC PACING WIRE | 04/10/1998 |
| K173923 | Ethicon, Inc. | Temporary Cardiac Pacing Wire | 08/02/2018 |
| K033858 | EUROPEAN CUSTOM MANUFACTURING BV | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | 07/12/2004 |
| K963073 | HARMAC MEDICAL PRODUCTS, INC. | HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET | 08/14/1997 |
| K962833 | HARMAC MEDICAL PRODUCTS, INC. | HARMAC TEMPORARY PACING CATHETER WITH BALLOON | 10/15/1997 |
| K190716 | Medtronic | 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 | 08/08/2019 |
| K171253 | Medtronic | 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 | 05/25/2017 |
| K161249 | Medtronic | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | 08/19/2016 |
| K242705 | Medtronic Inc | 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 T | 01/17/2025 |
| K040812 | MEDTRONIC VASCULAR | DETECT SURGICAL PACING AND MAPPING TOOL | 09/02/2004 |
| K973360 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD | 05/26/1998 |
| K042190 | MEDTRONIC VASCULAR | MODEL 6416 TEMPORARY PACING LEAD SYSTEM | 09/07/2004 |
| K012454 | MEDTRONIC VASCULAR | MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD | 08/14/2001 |
| K012458 | MEDTRONIC VASCULAR | MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD | 08/14/2001 |
| K012459 | MEDTRONIC VASCULAR | MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE | 08/14/2001 |
| K012460 | MEDTRONIC VASCULAR | MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD | 08/14/2001 |
| K963898 | MEDTRONIC VASCULAR | MODEL 6495 BIPOLAR TEMPORARY PACING LEAD | 07/22/1997 |
| K012452 | MEDTRONIC VASCULAR | MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD | 08/14/2001 |
| K961520 | MEDTRONIC VASCULAR | UNIPOLAR IPG GROUND CABLE, MODEL 5473 | 11/13/1996 |
| K140972 | MEDTRONIC, INC. | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING | 06/06/2014 |
| K072770 | Oscor Inc. | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | 01/22/2008 |
| K232261 | Osypka AG | TME Temporary Myocardial Electrode | 04/26/2024 |
| K032613 | PETER M. ROTHENBERG, M.D. | TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE | 11/20/2003 |
| K023174 | RIVER MEDICAL, INC. | DISPOSABLE TEMPORARY PACING WIRE | 06/11/2003 |
| K241199 | Shenzhen Launch Electrical Co. Ltd | Rotatable Connector (5944RL) | 01/23/2025 |
| K152784 | ST. JUDE MEDICAL | Pacel Bipolar Pacing Catheters | 10/22/2015 |
| K161873 | St. Jude Medical | Pacel Flow Directed Pacing Catheter | 11/22/2016 |
| K011660 | WECK CLOSURE SYSTEMS | WECK CARDIAC PACING WIRES | 08/21/2001 |
| K002603 | ZCV ,INC. | ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER | 01/08/2001 |
| K002481 | ZCV ,INC. | ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 | 12/07/2000 |
| K010099 | ZCV ,INC. | ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER | 02/01/2001 |
| K002687 | ZYNERGY CARDIOVASCULAR, INC. | ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 | 11/09/2000 |
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