Panels › Cardiovascular › Product code LDF · Class 2
Electrode, Pacemaker, Temporary
Regulation 870.3680
1510(k)s in 12 months (130 all time)
1recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in LDF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 21 | 0 |
| C.R. Bard, Inc. | 8 | 0 |
| Electro-Catheter Corp. | 7 | 0 |
| Medtronic | 5 | 1 |
| Oscor, Inc. | 4 | 2 |
| Cordis Corp. | 5 | 0 |
| ETHICON, Inc. | 5 | 0 |
| ARROW INTERNATIONAL, LLC | 0 | 4 |
| Oscor Medical Corp. | 4 | 0 |
| Daig Corp. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2026 | K252042 | Sync AV II Temporary Pacing Catheter Swift Sync, Inc. | LDF |
| Jun 15, 2025 | K242863 | Bioptimal Bipolar Pacing Catheter Bioptimal International Pte. , Ltd., SG | LDF |
| May 15, 2025 | K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) C.R. Bard, Inc. | LDF |
| Jan 31, 2025 | K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Flo C.R. Bard, Inc. | LDF |
| Jan 23, 2025 | K241199 | Rotatable Connector (5944RL) Shenzhen Launch Electrical Co., Ltd., CN | LDF |
| Jan 17, 2025 | K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Strea Medtronic, Inc. | LDF |
| Apr 26, 2024 | K232261 | TME Temporary Myocardial Electrode Osypka AG, DE | LDF |
| Aug 8, 2019 | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streaml Medtronic | LDF |
| Aug 2, 2018 | K173923 | Temporary Cardiac Pacing Wire ETHICON, Inc. | LDF |
| May 25, 2017 | K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 649 Medtronic | LDF |
| Nov 22, 2016 | K161873 | Pacel Flow Directed Pacing Catheter St Jude Medical | LDF |
| Oct 25, 2016 | K160260 | Tempo Temporary Pacing Lead Biotrace Medical, Inc. | LDF |
| Aug 19, 2016 | K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Medtronic | LDF |
| Oct 22, 2015 | K152784 | Pacel Bipolar Pacing Catheters St Jude Medical | LDF |
| Oct 15, 2015 | K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe Edwards Lifesciences, LLC | LDF |
| Jun 6, 2014 | K140972 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING Medtronic, Inc. | LDF |
| Jan 22, 2008 | K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) Oscor, Inc. | LDF |
| Sep 7, 2004 | K042190 | MODEL 6416 TEMPORARY PACING LEAD SYSTEM Medtronic Vascular | LDF |
| Sep 2, 2004 | K040812 | DETECT SURGICAL PACING AND MAPPING TOOL Medtronic Vascular | LDF |
| Jul 12, 2004 | K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE European Custom Manufacturing BV, NL | LDF |
| Nov 20, 2003 | K032613 | TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE Peter M. Rothenberg, M.D. | LDF |
| Jun 11, 2003 | K023174 | DISPOSABLE TEMPORARY PACING WIRE River Medical, Inc. | LDF |
| Apr 22, 2003 | K030556 | STEELEX ELECTRODE SET Aesculap, Inc. | LDF |
| Aug 21, 2001 | K011660 | WECK CARDIAC PACING WIRES Weck Closure Systems | LDF |
| Aug 14, 2001 | K012460 | MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD Medtronic Vascular | LDF |
| Aug 14, 2001 | K012459 | MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE Medtronic Vascular | LDF |
| Aug 14, 2001 | K012458 | MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD Medtronic Vascular | LDF |
| Aug 14, 2001 | K012454 | MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD Medtronic Vascular | LDF |
| Aug 14, 2001 | K012452 | MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD Medtronic Vascular | LDF |
| Feb 1, 2001 | K010099 | ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER Zcv ,Inc. | LDF |
| Jan 8, 2001 | K002603 | ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER Zcv ,Inc. | LDF |
| Dec 7, 2000 | K002481 | ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 Zcv ,Inc. | LDF |
| Nov 9, 2000 | K002687 | ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 Zynergy Cardiovascular, Inc. | LDF |
| May 26, 1998 | K973360 | MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular | LDF |
| Apr 10, 1998 | K980503 | TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. | LDF |
| Dec 29, 1997 | K971775 | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 Cardiac Control Systems, Inc. | LDF |
| Nov 18, 1997 | K955829 | SAFPACE SYSTEM B.Braun Medical, Inc. | LDF |
| Oct 15, 1997 | K962833 | HARMAC TEMPORARY PACING CATHETER WITH BALLOON Harmac Medical Products, Inc. | LDF |
| Aug 14, 1997 | K963073 | HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET Harmac Medical Products, Inc. | LDF |
| Jul 23, 1997 | K971165 | INTRODUCER SHEATH AND DILATOR Boston Scientific Corp | LDF |
| Jul 22, 1997 | K963898 | MODEL 6495 BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular | LDF |
| Nov 13, 1996 | K961520 | UNIPOLAR IPG GROUND CABLE, MODEL 5473 Medtronic Vascular | LDF |
| Oct 17, 1996 | K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER Arrow Intl., Inc. | LDF |
| Oct 11, 1996 | K955712 | USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING C.R. Bard, Inc. | LDF |
| Sep 17, 1996 | K962467 | RV PACING LEAD Abbott Laboratories | LDF |
| Mar 15, 1996 | K955722 | FLEXON TEMPORARY CARDIAC PACER LEAD Davis & Geck, Inc. | LDF |
| Dec 13, 1995 | K954809 | UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 Medtronic Vascular | LDF |
| Jul 27, 1995 | K934785 | MULTIPACE Electro-Catheter Corp. | LDF |
| Jul 14, 1995 | K944966 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 Medtronic Blood Systems, Inc. | LDF |
| Jul 14, 1995 | K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Blood Systems, Inc. | LDF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.