FDA Product Code
FDA Product Code LDF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3680
510(k) Clearances — 130 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252042 | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | 2026-07-30 | Traditional | PDF ↗ |
| K242863 | Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. | 2025-06-15 | Traditional | PDF ↗ |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. | 2025-05-15 | Special | PDF ↗ |
| 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. | 2025-01-31 | Traditional | PDF ↗ |
| K241199 | Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd. | 2025-01-23 | Traditional | PDF ↗ |
| 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. | 2025-01-17 | Special | PDF ↗ |
| K232261 | TME Temporary Myocardial Electrode | Osypka AG | 2024-04-26 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K173923 | Temporary Cardiac Pacing Wire | ETHICON, Inc. | 2018-08-02 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K161873 | Pacel Flow Directed Pacing Catheter | St Jude Medical | 2016-11-22 | Traditional | PDF ↗ |
| K160260 | Tempo Temporary Pacing Lead | Biotrace Medical, Inc. | 2016-10-25 | Traditional | PDF ↗ |
| K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | Medtronic | 2016-08-19 | Special | PDF ↗ |
| K152784 | Pacel Bipolar Pacing Catheters | St Jude Medical | 2015-10-22 | Special | PDF ↗ |
| K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe | Edwards Lifesciences, LLC | 2015-10-15 | Special | PDF ↗ |
| K140972 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING | Medtronic, Inc. | 2014-06-06 | Special | PDF ↗ |
| K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | Oscor, Inc. | 2008-01-22 | Traditional | PDF ↗ |
| K042190 | MODEL 6416 TEMPORARY PACING LEAD SYSTEM | Medtronic Vascular | 2004-09-07 | Special | PDF ↗ |
| K040812 | DETECT SURGICAL PACING AND MAPPING TOOL | Medtronic Vascular | 2004-09-02 | Traditional | PDF ↗ |
| K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | European Custom Manufacturing BV | 2004-07-12 | Traditional | PDF ↗ |
| K032613 | TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE | Peter M. Rothenberg, M.D. | 2003-11-20 | Traditional | PDF ↗ |
| K023174 | DISPOSABLE TEMPORARY PACING WIRE | River Medical, Inc. | 2003-06-11 | Traditional | PDF ↗ |
| K030556 | STEELEX ELECTRODE SET | Aesculap, Inc. | 2003-04-22 | Traditional | PDF ↗ |
| K011660 | WECK CARDIAC PACING WIRES | Weck Closure Systems | 2001-08-21 | Traditional | PDF ↗ |
| K012458 | MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD | Medtronic Vascular | 2001-08-14 | Special | PDF ↗ |
| K012452 | MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD | Medtronic Vascular | 2001-08-14 | Special | PDF ↗ |
| K012460 | MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD | Medtronic Vascular | 2001-08-14 | Special | PDF ↗ |
| K012454 | MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD | Medtronic Vascular | 2001-08-14 | Special | PDF ↗ |
| K012459 | MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE | Medtronic Vascular | 2001-08-14 | Special | PDF ↗ |
| K010099 | ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER | Zcv ,Inc. | 2001-02-01 | Special | PDF ↗ |
| K002603 | ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER | Zcv ,Inc. | 2001-01-08 | Traditional | PDF ↗ |
| K002481 | ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 | Zcv ,Inc. | 2000-12-07 | Traditional | PDF ↗ |
| K002687 | ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 | Zynergy Cardiovascular, Inc. | 2000-11-09 | Traditional | PDF ↗ |
| K973360 | MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD | Medtronic Vascular | 1998-05-26 | Traditional | PDF ↗ |
| K980503 | TEMPORARY CARDIAC PACING WIRE | ETHICON, Inc. | 1998-04-10 | Traditional | PDF ↗ |
| K971775 | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 | Cardiac Control Systems, Inc. | 1997-12-29 | Traditional | PDF ↗ |
| K955829 | SAFPACE SYSTEM | B.Braun Medical, Inc. | 1997-11-18 | Traditional | PDF ↗ |
| K962833 | HARMAC TEMPORARY PACING CATHETER WITH BALLOON | Harmac Medical Products, Inc. | 1997-10-15 | Traditional | PDF ↗ |
| K963073 | HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET | Harmac Medical Products, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K971165 | INTRODUCER SHEATH AND DILATOR | Boston Scientific Corp | 1997-07-23 | Traditional | PDF ↗ |
| K963898 | MODEL 6495 BIPOLAR TEMPORARY PACING LEAD | Medtronic Vascular | 1997-07-22 | Traditional | PDF ↗ |
| K961520 | UNIPOLAR IPG GROUND CABLE, MODEL 5473 | Medtronic Vascular | 1996-11-13 | Traditional | PDF ↗ |
| K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER | Arrow Intl., Inc. | 1996-10-17 | Traditional | PDF ↗ |
| K955712 | USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING | C.R. Bard, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K962467 | RV PACING LEAD | Abbott Laboratories | 1996-09-17 | Traditional | PDF ↗ |
| K955722 | FLEXON TEMPORARY CARDIAC PACER LEAD | Davis & Geck, Inc. | 1996-03-15 | Traditional | PDF ↗ |
| K954809 | UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 | Medtronic Vascular | 1995-12-13 | Traditional | PDF ↗ |
| K934785 | MULTIPACE | Electro-Catheter Corp. | 1995-07-27 | Traditional | PDF ↗ |
| K944966 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 | Medtronic Blood Systems, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K944956 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 | The Heart Valve Div. Medtronic Cardiovascular Surg | 1995-07-14 | Traditional | PDF ↗ |
| K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 | Medtronic Blood Systems, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K934787 | SILICORE SEMI-FLOATER | Electro-Catheter Corp. | 1995-02-24 | Traditional | PDF ↗ |
| K930069 | BIPOLAR BALLOON PACING CATHETER BY J-LLOYD | J-Lloyd Medical, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K924388 | ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD | Angemed, Inc. | 1993-10-21 | Traditional | PDF ↗ |
| K924390 | ANGEMED 5000 LEAD ADAPTER | Angemed, Inc. | 1993-08-25 | Traditional | PDF ↗ |
| K922182 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492 | Medtronic Vascular | 1992-11-23 | Traditional | PDF ↗ |
| K922269 | UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 | The Heart Valve Div. Medtronic Cardiovascular Surg | 1992-11-23 | Traditional | PDF ↗ |
| K922268 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491 | Medtronic Vascular | 1992-11-23 | Traditional | PDF ↗ |
| K923407 | MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES | Medtronic Vascular | 1992-10-19 | Traditional | PDF ↗ |
| K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER | Daig Corp. | 1992-01-27 | Traditional | PDF ↗ |
| K913521 | XEMEX TEMPORARY PACING CATHETER A MODIFIED | Zeon Medical Corp. | 1991-12-27 | Traditional | PDF ↗ |
| K904868 | XEMEX TEMPORARY PACING CATHETER A | Zeon Medical Corp. | 1991-05-16 | Traditional | PDF ↗ |
| K902342 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491 | Medtronic Vascular | 1990-10-16 | Traditional | PDF ↗ |
| K900982 | E-CLIP | Joel Cohen & Esther R. Cohen | 1990-04-19 | Traditional | PDF ↗ |
| K895789 | UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 | Medtronic Vascular | 1989-12-07 | Traditional | PDF ↗ |
| K890988 | MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE | Pace Medical | 1989-08-25 | Traditional | PDF ↗ |
| K890794 | DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER | Daig Corp. | 1989-06-20 | Traditional | PDF ↗ |
| K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | Oscor Medical Corp. | 1989-03-22 | Traditional | PDF ↗ |
| K882330 | BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER | C.R. Bard, Inc. | 1988-09-06 | Traditional | PDF ↗ |
| K882045 | HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK | Cordis Leads, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K881356 | EXTERNAL PACEMAKER WIRE DRESSING CHANGE | Neal & Assoc., Inc. | 1988-05-19 | Traditional | PDF ↗ |
| K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE | Daig Corp. | 1988-02-12 | Traditional | PDF ↗ |
| K874310 | WIRE DRESSING | Slocum and Neal, Inc. | 1987-12-23 | Traditional | PDF ↗ |
| K872972 | TEMPORARY PACEMAKER ELECTRODE | Oscor Medical Corp. | 1987-12-03 | Traditional | PDF ↗ |
| K873728 | DEKNATEL TEMPORARY CARDIAC PACING WIRE | Deknatel, Inc. | 1987-11-03 | Traditional | PDF ↗ |
| K873474 | SUTURELESS TEMPORARY EPICARDIAL PACING LEAD | Symbion, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K873716 | ADULT WALKING HEEL PRODUCT NO. 4183-130 | Martin Medical | 1987-10-02 | Traditional | PDF ↗ |
| K862970 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 | Medtronic Vascular | 1987-09-25 | Traditional | PDF ↗ |
| K864507 | V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 | Spectramed, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K861403 | TB SERIES BIPOLAR PACING LEADS | Oscor Medical Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K861409 | SYNCARE TEMPORARY CARDIAC PACING WIRE | Gyneco, Inc. | 1986-05-05 | Traditional | PDF ↗ |
| K855139 | FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT | Davis & Geck, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K853818 | MEDTRONIC MODEL 6405 | Medtronic Vascular | 1985-10-11 | Traditional | PDF ↗ |
| K852797 | HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE | Mansfield Scientific, Inc. | 1985-09-16 | Traditional | PDF ↗ |
| K851913 | CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA | Cordis Corp. | 1985-09-16 | Traditional | PDF ↗ |
| K852513 | 115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD | C.R. Bard, Inc. | 1985-09-16 | Traditional | PDF ↗ |
| K851845 | NUMED TEMP. STYLET PACING PAROBE 1318694 | NuMED, Inc. | 1985-08-29 | Traditional | PDF ↗ |
| K851246 | NUMED BALLOON PACING CATHETER | NuMED, Inc. | 1985-04-19 | Traditional | PDF ↗ |
| K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | Oscor Medical Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER | Electro-Catheter Corp. | 1985-03-27 | Traditional | PDF ↗ |
| K843290 | NUMED BALLOON PACING CATHETER | NuMED, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K844003 | ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH | Electro-Catheter Corp. | 1984-12-27 | Traditional | PDF ↗ |
| K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | Webster Laboratories, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K843141 | CRITIKON HEPARIN-COATED CARDIOVASCULAR | Critikon Company, LLC | 1984-09-04 | Traditional | PDF ↗ |
| K834416 | LUMELEC ELECTRODE CATHETER | Cordis Corp. | 1984-04-24 | Traditional | PDF ↗ |
| K840109 | ELECATH HEPARIN COATED TEMP. PACING | Electro-Catheter Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 | Oscor, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K831804 | MULTIPOLAR TEMPORARY CARDIAC | Oscor, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K832561 | EPCOR MULTIELECTRODE TEMP. PERVENOUS | Cordis Corp. | 1983-10-19 | Traditional | PDF ↗ |
| K832850 | ELECATH PACEWEDGE DUAL PRESS. BIPOLAR | Electro-Catheter Corp. | 1983-10-19 | Traditional | PDF ↗ |
Product code LDF · Class II · Cardiovascular. Data: openFDA.