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 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 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
Cleared Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789
Medtronic Vascular
Cardiovascular · 70d
Cleared Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794
Daig Corp.
Cardiovascular · 123d
Cleared Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Feb 12, 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059
Daig Corp.
Cardiovascular · 65d
Cleared Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728
Deknatel, Inc.
Cardiovascular · 48d
Cleared Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970
Medtronic Vascular
Cardiovascular · 415d
Cleared Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139
Davis & Geck, Inc.
Cardiovascular · 65d
Cleared Oct 11, 1985
MEDTRONIC MODEL 6405
K853818
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913
Cordis Corp.
Cardiovascular · 138d