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 Electro-Catheter Corp..

129
Total
129
Cleared
134d
Avg days
1978
Since
129 devices
25–48 of 129
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 Apr 10, 1998
TEMPORARY CARDIAC PACING WIRE
K980503
Ethicon, Inc.
Cardiovascular · 60d
Cleared Dec 29, 1997
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
K971775
Cardiac Control Systems, Inc.
Cardiovascular · 230d
Cleared Nov 18, 1997
SAFPACE SYSTEM
K955829
B.Braun Medical, Inc.
Cardiovascular · 693d
Cleared Oct 15, 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833
Harmac Medical Products, Inc.
Cardiovascular · 474d
Cleared Aug 14, 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073
Harmac Medical Products, Inc.
Cardiovascular · 412d
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 17, 1996
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
K960479
Arrow Intl., Inc.
Cardiovascular · 258d
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 Mar 15, 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722
Davis & Geck, Inc.
Cardiovascular · 88d
Cleared Dec 13, 1995
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809
Medtronic Vascular
Cardiovascular · 55d
Cleared Jul 27, 1995
MULTIPACE
K934785
Electro-Catheter Corp.
Cardiovascular · 660d
Cleared Feb 24, 1995
SILICORE SEMI-FLOATER
K934787
Electro-Catheter Corp.
Cardiovascular · 507d
Cleared Jan 28, 1994
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069
J-Lloyd Medical, Inc.
Cardiovascular · 387d
Cleared Nov 23, 1992
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182
Medtronic Vascular
Cardiovascular · 196d
Cleared Nov 23, 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268
Medtronic Vascular
Cardiovascular · 193d
Cleared Oct 19, 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407
Medtronic Vascular
Cardiovascular · 101d
Cleared Jan 27, 1992
PACEL(TM) FLOW DIRECTED PACING CATHETER
K914185
Daig Corp.
Cardiovascular · 131d
Cleared Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342
Medtronic Vascular
Cardiovascular · 144d