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
128 devices
25–48 of 128
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 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 Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970
Medtronic Vascular
Cardiovascular · 415d
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
Cleared Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513
C.R. Bard, Inc.
Cardiovascular · 96d
Cleared Apr 24, 1984
LUMELEC ELECTRODE CATHETER
K834416
Cordis Corp.
Cardiovascular · 131d
Cleared Oct 19, 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
K832561
Cordis Corp.
Cardiovascular · 79d
Cleared Feb 18, 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
K830094
C.R. Bard, Inc.
Cardiovascular · 38d
Cleared Nov 16, 1981
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
K812725
Medtronic Vascular
Cardiovascular · 49d
Cleared Oct 29, 1981
TEMPORARY PERVENOUS J-ATRIAL LEAD
K812781
Cordis Corp.
Cardiovascular · 24d
Cleared Sep 21, 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
K812307
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Jul 20, 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
K811318
Medtronic Vascular
Cardiovascular · 69d
Cleared Apr 08, 1981
TEMPTRON #'S 6804/6805
K810657
Medtronic Vascular
Cardiovascular · 28d
Cleared Feb 05, 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041
Cordis Corp.
Cardiovascular · 29d
Cleared Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
K800298
C.R. Bard, Inc.
Cardiovascular · 65d