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
K971165 BOSTON SCIENTIFIC CORP. INTRODUCER SHEATH AND DILATOR 07/23/1997
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
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
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
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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