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
K821518 ALTO DEVELOPMENT CORP. MYO/CLIP 07/08/1982
K803058 AMERICAN EDWARDS LABORATORIES SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. 01/16/1981
K813521 AMERICAN EDWARDS LABORATORIES TRANSLUMINAL BIPOLAR PACING PROBE 03/15/1982
K924390 ANGEMED, INC. ANGEMED 5000 LEAD ADAPTER 08/25/1993
K924388 ANGEMED, INC. ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD 10/21/1993
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
K852513 C.R. BARD, INC. 115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD 09/16/1985
K882330 C.R. BARD, INC. BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER 09/06/1988
K800298 C.R. BARD, INC. USCI BIPOLAR BALLON PACING ELECTRODE 04/16/1980
K955712 C.R. BARD, INC. USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING 10/11/1996
K830094 C.R. BARD, INC. USCI TEMP. ATRIO-VENTRICULAR ELECTRODE 02/18/1983
K812307 C.R. BARD, INC. USCI TRANSTHORACIC TEMP. PACING ELECTROD 09/21/1981
K971775 CARDIAC CONTROL SYSTEMS, INC. INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 12/29/1997
K831645 CORDIC CORP. TEMP. BIPOLAR EPICARDIAL LEAD 07/26/1983
K851913 CORDIS CORP. CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA 09/16/1985
K810041 CORDIS CORP. CORDIS TEMPORATY CURVED ATRIAL LEAD 02/05/1981
K832561 CORDIS CORP. EPCOR MULTIELECTRODE TEMP. PERVENOUS 10/19/1983
K834416 CORDIS CORP. LUMELEC ELECTRODE CATHETER 04/24/1984
K812781 CORDIS CORP. TEMPORARY PERVENOUS J-ATRIAL LEAD 10/29/1981
K882045 CORDIS LEADS, INC. HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK 07/12/1988
K803086 CRAIG & CRAIG, INC. MYOWIRE-ATEMPORARY CARDIAC PACING WIRE 07/01/1981
K843141 CRITIKON COMPANY,LLC CRITIKON HEPARIN-COATED CARDIOVASCULAR 09/04/1984
K890794 DAIG CORP. DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER 06/20/1989
K875059 DAIG CORP. DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE 02/12/1988
K914185 DAIG CORP. PACEL(TM) FLOW DIRECTED PACING CATHETER 01/27/1992
K855139 DAVIS & GECK, INC. FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT 02/26/1986
K955722 DAVIS & GECK, INC. FLEXON TEMPORARY CARDIAC PACER LEAD 03/15/1996
K873728 DEKNATEL, INC. DEKNATEL TEMPORARY CARDIAC PACING WIRE 11/03/1987
K820003 DIAG CORP. CARDIOVASCULAR TEMP. PACEMAKER ELEC 03/26/1982
K152633 EDWARDS LIFESCIENCES, LLC Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe 10/15/2015
K791183 EDWARDS LIFESCIENCES, LLC. SWAN-GANZ FLOW-DIRECTED CATHETER 07/12/1979
K810312 ELECTRO-CATHETER CORP. ELECATH DUAL MODE TRANSTHORACIC PACING 03/04/1981
K840109 ELECTRO-CATHETER CORP. ELECATH HEPARIN COATED TEMP. PACING 02/04/1984
K850324 ELECTRO-CATHETER CORP. ELECATH OPEN TIP BIPOLAR PACING CATHETER 03/27/1985
K832850 ELECTRO-CATHETER CORP. ELECATH PACEWEDGE DUAL PRESS. BIPOLAR 10/19/1983
K844003 ELECTRO-CATHETER CORP. ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH 12/27/1984
K934785 ELECTRO-CATHETER CORP. MULTIPACE 07/27/1995
K934787 ELECTRO-CATHETER CORP. SILICORE SEMI-FLOATER 02/24/1995
K813138 ETHICON, INC. ETHICON* TEMP. CARDIAC PACING WIRE 12/10/1981
K781002 ETHICON, INC. TEMPORARY CARDIAC PACING WIRE 12/04/1978
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
K861409 GYNECO, INC. SYNCARE TEMPORARY CARDIAC PACING WIRE 05/05/1986
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
K930069 J-LLOYD MEDICAL, INC. BIPOLAR BALLOON PACING CATHETER BY J-LLOYD 01/28/1994
K900982 JOEL COHEN & ESTHER R. COHEN E-CLIP 04/19/1990
K852797 MANSFIELD SCIENTIFIC, INC. HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE 09/16/1985
K873716 MARTIN MEDICAL ADULT WALKING HEEL PRODUCT NO. 4183-130 10/02/1987
K801799 MEDICAL TESTING SYSTEM, INC. ATRIAL/VENTRICULAR SEQENTIAL #080-20000 01/02/1981
K801800 MEDICAL TESTING SYSTEM, INC. UNIVERSAL TEMP. PACING ELECT. #080-10000 10/23/1980
K821333 MEDICS INSTRUMENT CORP. ATRIAL "J" TEMPORARY PACING ELECTRODESS 06/02/1982
K812517 MEDICS INSTRUMENT CORP. CARDIAC PACING ELECTRODES 10/13/1981
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
K944957 MEDTRONIC BLOOD SYSTEMS, INC. TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 07/14/1995
K944966 MEDTRONIC BLOOD SYSTEMS, INC. UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 07/14/1995
K040812 MEDTRONIC VASCULAR DETECT SURGICAL PACING AND MAPPING TOOL 09/02/2004
K853818 MEDTRONIC VASCULAR MEDTRONIC MODEL 6405 10/11/1985
K973360 MEDTRONIC VASCULAR MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD 05/26/1998
K923407 MEDTRONIC VASCULAR MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES 10/19/1992
K812725 MEDTRONIC VASCULAR MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD 11/16/1981
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
K811318 MEDTRONIC VASCULAR TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 07/20/1981
K862970 MEDTRONIC VASCULAR TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 09/25/1987
K810657 MEDTRONIC VASCULAR TEMPTRON #'S 6804/6805 04/08/1981
K922182 MEDTRONIC VASCULAR UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492 11/23/1992
K961520 MEDTRONIC VASCULAR UNIPOLAR IPG GROUND CABLE, MODEL 5473 11/13/1996
K922268 MEDTRONIC VASCULAR UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491 11/23/1992
K902342 MEDTRONIC VASCULAR UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491 10/16/1990
K895789 MEDTRONIC VASCULAR UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 12/07/1989
K954809 MEDTRONIC VASCULAR UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 12/13/1995
K140972 MEDTRONIC, INC. UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING 06/06/2014
K881356 NEAL & ASSOC., INC. EXTERNAL PACEMAKER WIRE DRESSING CHANGE 05/19/1988
K843290 NUMED, INC. NUMED BALLOON PACING CATHETER 01/14/1985
K851246 NUMED, INC. NUMED BALLOON PACING CATHETER 04/19/1985
K851845 NUMED, INC. NUMED TEMP. STYLET PACING PAROBE 1318694 08/29/1985
K831804 OSCOR INC. MULTIPOLAR TEMPORARY CARDIAC 10/20/1983
K831695 OSCOR INC. TEMP. CARDIAC PACING WIRE TME 60/61/65 10/20/1983
K830772 OSCOR INC. TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 04/18/1983
K072770 Oscor Inc. TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) 01/22/2008
K861403 OSCOR MEDICAL CORP. "TB SERIES" BIPOLAR PACING LEADS 06/27/1986
K850622 OSCOR MEDICAL CORP. OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR 04/10/1985
K884866 OSCOR MEDICAL CORP. TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 03/22/1989
K872972 OSCOR MEDICAL CORP. TEMPORARY PACEMAKER ELECTRODE 12/03/1987
K890988 PACE MEDICAL MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE 08/25/1989
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
K874310 SLOCUM AND NEAL, INC. WIRE DRESSING 12/23/1987
K864507 SPECTRAMED, INC. V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 03/06/1987
K152784 ST. JUDE MEDICAL Pacel Bipolar Pacing Catheters 10/22/2015
K161873 St. Jude Medical Pacel Flow Directed Pacing Catheter 11/22/2016
K810642 STANCO MEDICAL, INC. ATRIAL-VENTRICULAR PACING ELECTRODE KIT 04/08/1981
K802259 STANCO MEDICAL, INC. TRANSVENOUS PACEMAKER ELECTRODE KIT 10/23/1980
K810643 STANCO MEDICAL, INC. UNIVERSAL PACING ELECTRODE KIT 04/08/1981
K873474 SYMBION, INC. SUTURELESS TEMPORARY EPICARDIAL PACING LEAD 10/07/1987
K944956 THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 07/14/1995
K922269 THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 11/23/1992
K820232 TRANS PACE, INC. TRANSTHORACIC TEMP. PACEMAKER #100TPE 04/09/1982
K841802 WEBSTER LABORATORIES, INC. ELECTRODE CATHETER, ORTHOGONAL TYPE 10/18/1984
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
K904868 ZEON MEDICAL CORP. XEMEX TEMPORARY PACING CATHETER A 05/16/1991
K913521 ZEON MEDICAL CORP. XEMEX TEMPORARY PACING CATHETER A MODIFIED 12/27/1991
K822003 ZIEHM INTERNATIONAL, INC. BALLOON TEMP. PACING CATHETER 10/15/1982
K822002 ZIEHM INTERNATIONAL, INC. BIPOLAR TEMP. PACING CATHETER W/STYLETET 10/15/1982
K002687 ZYNERGY CARDIOVASCULAR, INC. ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 11/09/2000


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