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 Jul 14, 1995
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
K944956
The Heart Valve Div. Medtronic Cardiovascular Surg
Cardiovascular · 280d
Cleared Jul 14, 1995
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K944957
Medtronic Blood Systems, Inc.
Cardiovascular · 280d
Cleared Jul 14, 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
K944966
Medtronic Blood Systems, Inc.
Cardiovascular · 276d
Cleared Feb 24, 1995
SILICORE SEMI-FLOATER
K934787
Electro-Catheter Corp.
Cardiovascular · 507d
Cleared Jan 28, 1994
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069
J-Lloyd Medical, Inc.
Cardiovascular · 387d
Cleared Oct 21, 1993
ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD
K924388
Angemed, Inc.
Cardiovascular · 416d
Cleared Aug 25, 1993
ANGEMED 5000 LEAD ADAPTER
K924390
Angemed, Inc.
Cardiovascular · 359d
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 Nov 23, 1992
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
K922269
The Heart Valve Div. Medtronic Cardiovascular Surg
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 Dec 27, 1991
XEMEX TEMPORARY PACING CATHETER A MODIFIED
K913521
Zeon Medical Corp.
Cardiovascular · 143d
Cleared May 16, 1991
XEMEX TEMPORARY PACING CATHETER A
K904868
Zeon Medical Corp.
Cardiovascular · 199d
Cleared Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342
Medtronic Vascular
Cardiovascular · 144d
Cleared Apr 19, 1990
E-CLIP
K900982
Joel Cohen & Esther R. Cohen
Cardiovascular · 48d
Cleared Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789
Medtronic Vascular
Cardiovascular · 70d
Cleared Aug 25, 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
K890988
Pace Medical
Cardiovascular · 179d
Cleared Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794
Daig Corp.
Cardiovascular · 123d
Cleared Mar 22, 1989
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
K884866
Oscor Medical Corp.
Cardiovascular · 121d
Cleared Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Jul 12, 1988
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
K882045
Cordis Leads, Inc.
Cardiovascular · 57d
Cleared May 19, 1988
EXTERNAL PACEMAKER WIRE DRESSING CHANGE
K881356
Neal & Assoc., Inc.
Cardiovascular · 52d
Cleared Feb 12, 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059
Daig Corp.
Cardiovascular · 65d