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
49–72 of 129
Cleared Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513
C.R. Bard, Inc.
Cardiovascular · 96d
Cleared Aug 29, 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845
NuMED, Inc.
Cardiovascular · 125d
Cleared Apr 19, 1985
NUMED BALLOON PACING CATHETER
K851246
NuMED, Inc.
Cardiovascular · 25d
Cleared Mar 27, 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Jan 14, 1985
NUMED BALLOON PACING CATHETER
K843290
NuMED, Inc.
Cardiovascular · 146d
Cleared Dec 27, 1984
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003
Electro-Catheter Corp.
Cardiovascular · 76d
Cleared Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141
Critikon Company, LLC
Cardiovascular · 26d
Cleared Apr 24, 1984
LUMELEC ELECTRODE CATHETER
K834416
Cordis Corp.
Cardiovascular · 131d
Cleared Feb 04, 1984
ELECATH HEPARIN COATED TEMP. PACING
K840109
Electro-Catheter Corp.
Cardiovascular · 25d
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 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 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 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 Mar 04, 1981
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312
Electro-Catheter Corp.
Cardiovascular · 27d
Cleared Feb 05, 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041
Cordis Corp.
Cardiovascular · 29d