LDF · Class II · 21 CFR 870.3680

FDA Product Code LDF: Electrode, Pacemaker, Temporary

Temporary pacemakers provide immediate cardiac pacing during hemodynamic emergencies. FDA product code LDF covers temporary pacemaker electrodes used for short-term cardiac stimulation.

These catheters are placed transvenously or epicardially to deliver electrical impulses to the myocardium for temporary rate support during symptomatic bradycardia, post-cardiac surgery, and as a bridge to permanent pacemaker implantation.

LDF devices are Class II medical devices, regulated under 21 CFR 870.3680 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic Vascular, C.R. Bard, Inc. and Cordis Corp..

128
Total
128
Cleared
132d
Avg days
1978
Since
Growing category - 5 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 192d recently vs 129d historically

FDA 510(k) Cleared Electrode, Pacemaker, Temporary Devices (Product Code LDF)

128 devices
1–24 of 128
Cleared Jun 15, 2025
Bioptimal Bipolar Pacing Catheter
K242863
Bioptimal International Pte. , Ltd.
Cardiovascular · 268d
Cleared May 15, 2025
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Jan 31, 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P)
K241334
C.R. Bard, Inc.
Cardiovascular · 266d
Cleared Jan 23, 2025
Rotatable Connector (5944RL)
K241199
Shenzhen Launch Electrical Co., Ltd.
Cardiovascular · 268d
Cleared Jan 17, 2025
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)
K242705
Medtronic, Inc.
Cardiovascular · 130d
Cleared Apr 26, 2024
TME Temporary Myocardial Electrode
K232261
Osypka AG
Cardiovascular · 270d
Cleared Aug 08, 2019
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
K190716
Medtronic
Cardiovascular · 142d
Cleared Aug 02, 2018
Temporary Cardiac Pacing Wire
K173923
Ethicon, Inc.
Cardiovascular · 219d
Cleared Jun 06, 2014
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
K140972
Medtronic, Inc.
Cardiovascular · 51d
Cleared Sep 07, 2004
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190
Medtronic Vascular
Cardiovascular · 26d
Cleared Sep 02, 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812
Medtronic Vascular
Cardiovascular · 157d
Cleared Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
K012454
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459
Medtronic Vascular
Cardiovascular · 13d
Cleared Aug 14, 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460
Medtronic Vascular
Cardiovascular · 13d
Cleared May 26, 1998
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
K973360
Medtronic Vascular
Cardiovascular · 260d
Cleared Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
K971165
Boston Scientific Corp
Cardiovascular · 114d
Cleared Jul 22, 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898
Medtronic Vascular
Cardiovascular · 298d
Cleared Nov 13, 1996
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520
Medtronic Vascular
Cardiovascular · 205d
Cleared Oct 11, 1996
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
K955712
C.R. Bard, Inc.
Cardiovascular · 301d
Cleared Sep 17, 1996
RV PACING LEAD
K962467
Abbott Laboratories
Cardiovascular · 84d
Cleared Dec 13, 1995
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809
Medtronic Vascular
Cardiovascular · 55d
Cleared Nov 23, 1992
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182
Medtronic Vascular
Cardiovascular · 196d

About Product Code LDF - Regulatory Context

510(k) Submission Activity

128 total 510(k) submissions under product code LDF since 1978, with 128 receiving FDA clearance (average review time: 132 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LDF Product Code

Recent submissions under LDF have taken an average of 192 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.

LDF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →