LDF

Product Code: LDF


Products Classified as LDF

862Electrode, Pacemaker, TemporaryCardiovascular Permanent Or Temporary Pacemaker Electrode.

Total Product Life Cycle (TPLC) Devices

862Electrode, Pacemaker, TemporaryCardiovascular Permanent Or Temporary Pacemaker Electrode.

FDA Consensus Standards

Electrode, Pacemaker, Temporary [36797]21 CFR §870.3680 🔎
Electrode, Pacemaker, Temporary [36799]21 CFR §870.3680 🔎

Pre-market Notifications for LDF

K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing LeadMedtronic
K182582Oryum And Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLC
K173923Temporary Cardiac Pacing WireEthicon, Inc.
K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing LeadMedtronic
K161873Pacel Flow Directed Pacing CatheterSt. Jude Medical
K161249Streamline 6495 Bipolar Temporary Myocardial Pacing LeadMedtronic
K160260Tempo Temporary Pacing LeadBIO TRACE MEDICAL, INC.
K152784Pacel Bipolar Pacing CathetersST. JUDE MEDICAL
K152633Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeEDWARDS LIFESCIENCES, LLC
K140972UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACINGMEDTRONIC, INC.
K072770TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)Oscor Inc.
K042190MODEL 6416 TEMPORARY PACING LEAD SYSTEMMEDTRONIC VASCULAR
K040812DETECT SURGICAL PACING AND MAPPING TOOLMEDTRONIC VASCULAR
K033858TEMPORARY BIPOLAR MYOCARDIAL PACING WIREEUROPEAN CUSTOM MANUFACTURING BV
K032613TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICEPETER M. ROTHENBERG, M.D.

Global Unique Device Identification Database

20613994755623ELECTRODE, PACEMAKER, TEMPORARY
00613994377890ELECTRODE, PACEMAKER, TEMPORARY
20613994365433ELECTRODE, PACEMAKER, TEMPORARY
20613994365426ELECTRODE, PACEMAKER, TEMPORARY
20613994365419ELECTRODE, PACEMAKER, TEMPORARY
20613994361060ELECTRODE, PACEMAKER, TEMPORARY
20613994361053ELECTRODE, PACEMAKER, TEMPORARY
00643169372764ELECTRODE, PACEMAKER, TEMPORARY
00643169372757ELECTRODE, PACEMAKER, TEMPORARY
00643169372740ELECTRODE, PACEMAKER, TEMPORARY
20643169310111ELECTRODE, PACEMAKER, TEMPORARY
20643169310104ELECTRODE, PACEMAKER, TEMPORARY
20643169310098ELECTRODE, PACEMAKER, TEMPORARY
20643169310081ELECTRODE, PACEMAKER, TEMPORARY
20643169310074ELECTRODE, PACEMAKER, TEMPORARY

Maude Adverse Events

MYO/WIRE? ULTRA-THIN TEMPORARY PACING WIRESA E MEDICAL CORPORATION2020-03-19
NBIH? TEMPORARY PACING ELECTRODE CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-03-13
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CMC.R. BARD, INC. (COVINGTON) -10182332020-03-12
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CMC.R. BARD, INC. (COVINGTON) -10182332020-03-12
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2020-03-04
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2020-03-04
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2020-02-19
SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)EDWARDS LIFESCIENCES, PR2020-02-19
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 4FR 110CMC.R. BARD, INC. (COVINGTON) -10182332020-02-13
NBIH? TEMPORARY PACING ELECTRODE CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-01-31
TEMPORARY PACING LEADMEDTRONIC HEART VALVES DIVISION2020-01-28
PACEL BIPOLAR PACING CATHETERST. JUDE MEDICAL2020-01-20
WEBSTER? ELECTROPHYSIOLOGY CATHETERBIOSENSE WEBSTER INC2020-01-17
TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL, INC.2020-01-17
COURNAND SEMI-FLOATING TEMPORARY PACING ELECTRODE, 6FR 125CMC.R. BARD, INC. (COVINGTON) -10182332020-01-17
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2020-01-16
N/AELECTRODE, PACEMAKER, TEMPORARYC. R. BARD, INC.2020-01-16
PACEL BIPOLAR PACING CATHETERST. JUDE MEDICAL2020-01-08
SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTIONEDWARDS LIFESCIENCES, PR2020-01-07
SWAN-GANZ THERMODILUTION PACEPORT CATHETEREDWARDS LIFESCIENCES, PR2020-01-06
BIPOLAR TEMPORARY MYOCARDIAL PACING LEADMEDTRONIC HEART VALVES DIVISION2020-01-03
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CMC.R. BARD, INC. (COVINGTON) -10182332020-01-03
TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL, INC.2019-11-01
PACEL BIPOLAR PACING CATHETERST. JUDE MEDICAL2019-10-31
TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL, INC.2019-10-26
MEDTRONICMEDTRONIC HEART VALVES DIVISION2019-10-24
BIOTRACE TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL, INC.2019-10-23
TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL, INC.2019-10-23
MYO/WIRE? ULTRA-THIN TEMPORARY PACING WIRESA E MEDICAL CORPORATION2019-10-23
MEDTRONIC DUAL CHAMBER TEMPORARY PACEMAKERMEDTRONIC2019-10-17
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-10-16
OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KITC.R. BARD, INC. (COVINGTON) -10182332019-10-15
OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KITC.R. BARD, INC. (COVINGTON) -10182332019-10-15
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-10-14
TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL INC.2019-10-10
PATIENT CABLEMEDTRONIC, INC.2019-10-07
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-10-03
WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGYBIOSENSE WEBSTER INC.2019-09-26
WEBSTER? ELECTROPHYSIOLOGY CATHETER WITH AUTO IDBIOSENSE WEBSTER INC.2019-09-26
OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KIT, 5FR 110CMC.R. BARD, INC. (COVINGTON) -10182332019-09-18
TEMPO TEMPORARY PACING LEADBIOTRACE MEDICAL, INC.2019-09-13
SWAN-GANZ THERMODILUTION PACEPORT CATHETEREDWARDS LIFESCIENCES, PR2019-09-13
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-09-11
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-09-11
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CMC.R. BARD, INC. (COVINGTON) -10182332019-09-04
BALLOON BIPOLAR TEMPORARY PACING, ELECTRODE CATHETER, STAINLESS STEEL ELECTRODESC.R. BARD, INC. (COVINGTON) -10182332019-08-22
BALLOON BIPOLAR TEMPORARY PACING ELECTRODEC.R. BARD, INC. (COVINGTON) -10182332019-08-16
SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTIONEDWARDS LIFESCIENCES, PR2019-08-15
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-08-15
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTIONEDWARDS LIFESCIENCES, PR2019-08-15
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