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
Cleared
Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
Medtronic Vascular
Cardiovascular
70d
Cleared
Aug 25, 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
Pace Medical
Cardiovascular
179d
Cleared
Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
Daig Corp.
Cardiovascular
123d
Cleared
Mar 22, 1989
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
Oscor Medical Corp.
Cardiovascular
121d
Cleared
Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
C.R. Bard, Inc.
Cardiovascular
92d
Cleared
Feb 12, 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
Daig Corp.
Cardiovascular
65d
Cleared
Dec 03, 1987
TEMPORARY PACEMAKER ELECTRODE
Oscor Medical Corp.
Cardiovascular
127d
Cleared
Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
Deknatel, Inc.
Cardiovascular
48d
Cleared
Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
Medtronic Vascular
Cardiovascular
415d
Cleared
Jun 27, 1986
TB SERIES BIPOLAR PACING LEADS
Oscor Medical Corp.
Cardiovascular
73d
Cleared
Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
Davis & Geck, Inc.
Cardiovascular
65d
Cleared
Oct 11, 1985
MEDTRONIC MODEL 6405
Medtronic Vascular
Cardiovascular
29d
Cleared
Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
Cordis Corp.
Cardiovascular
138d
Cleared
Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
C.R. Bard, Inc.
Cardiovascular
96d
Cleared
Aug 29, 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
NuMED, Inc.
Cardiovascular
125d
Cleared
Apr 19, 1985
NUMED BALLOON PACING CATHETER
NuMED, Inc.
Cardiovascular
25d
Cleared
Apr 10, 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
Oscor Medical Corp.
Cardiovascular
50d
Cleared
Mar 27, 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
Electro-Catheter Corp.
Cardiovascular
58d
Cleared
Jan 14, 1985
NUMED BALLOON PACING CATHETER
NuMED, Inc.
Cardiovascular
146d
Cleared
Dec 27, 1984
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
Electro-Catheter Corp.
Cardiovascular
76d
Cleared
Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
Critikon Company, LLC
Cardiovascular
26d
Cleared
Apr 24, 1984
LUMELEC ELECTRODE CATHETER
Cordis Corp.
Cardiovascular
131d
Cleared
Feb 04, 1984
ELECATH HEPARIN COATED TEMP. PACING
Electro-Catheter Corp.
Cardiovascular
25d
Cleared
Oct 20, 1983
TEMP. CARDIAC PACING WIRE TME 60/61/65
Oscor, Inc.
Cardiovascular
148d