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
97–120 of 129
Cleared Oct 20, 1983
TEMP. CARDIAC PACING WIRE TME 60/61/65
K831695
Oscor, Inc.
Cardiovascular · 148d
Cleared Oct 20, 1983
MULTIPOLAR TEMPORARY CARDIAC
K831804
Oscor, Inc.
Cardiovascular · 139d
Cleared Oct 19, 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
K832561
Cordis Corp.
Cardiovascular · 79d
Cleared Oct 19, 1983
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR
K832850
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Jul 26, 1983
TEMP. BIPOLAR EPICARDIAL LEAD
K831645
Cordic Corp.
Cardiovascular · 64d
Cleared Apr 18, 1983
TEMP. PACING LEAD, BIPOLAR #TH60, 90/110
K830772
Oscor, Inc.
Cardiovascular · 38d
Cleared Feb 18, 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
K830094
C.R. Bard, Inc.
Cardiovascular · 38d
Cleared Oct 15, 1982
BIPOLAR TEMP. PACING CATHETER W/STYLETET
K822002
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
BALLOON TEMP. PACING CATHETER
K822003
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Jul 08, 1982
MYO/CLIP
K821518
Alto Development Corp.
Cardiovascular · 48d
Cleared Jun 02, 1982
ATRIAL J TEMPORARY PACING ELECTRODESS
K821333
Medics Instrument Corp.
Cardiovascular · 28d
Cleared Apr 09, 1982
TRANSTHORACIC TEMP. PACEMAKER #100TPE
K820232
Trans Pace, Inc.
Cardiovascular · 71d
Cleared Mar 26, 1982
CARDIOVASCULAR TEMP. PACEMAKER ELEC
K820003
Diag Corp.
Cardiovascular · 81d
Cleared Mar 15, 1982
TRANSLUMINAL BIPOLAR PACING PROBE
K813521
American Edwards Laboratories
Cardiovascular · 89d
Cleared Dec 10, 1981
ETHICON* TEMP. CARDIAC PACING WIRE
K813138
Ethicon, Inc.
Cardiovascular · 34d
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 Oct 13, 1981
CARDIAC PACING ELECTRODES
K812517
Medics Instrument Corp.
Cardiovascular · 41d
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 Jul 01, 1981
MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
K803086
Craig & Craig, Inc.
Cardiovascular · 205d
Cleared Apr 08, 1981
ATRIAL-VENTRICULAR PACING ELECTRODE KIT
K810642
Stanco Medical, Inc.
Cardiovascular · 29d
Cleared Apr 08, 1981
UNIVERSAL PACING ELECTRODE KIT
K810643
Stanco Medical, Inc.
Cardiovascular · 29d
Cleared Apr 08, 1981
TEMPTRON #'S 6804/6805
K810657
Medtronic Vascular
Cardiovascular · 28d