LDF — Electrode, Pacemaker, Temporary Class II

FDA Device Classification

Classification Details

Product Code
LDF
Device Class
Class II
Regulation Number
870.3680
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242863bioptimal international pte.Bioptimal Bipolar Pacing CatheterJune 15, 2025
K251186c.r. bardBard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)May 15, 2025
K241334c.r. bardSemi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel ElecJanuary 31, 2025
K241199shenzhen launch electrical coRotatable Connector (5944RL)January 23, 2025
K242705medtronicStreamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar TJanuary 17, 2025
K232261osypkaTME Temporary Myocardial ElectrodeApril 26, 2024
K190716medtronicStreamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 UnipolAugust 8, 2019
K173923ethiconTemporary Cardiac Pacing WireAugust 2, 2018
K171253medtronicStreamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 UnipolMay 25, 2017
K161873st jude medicalPacel Flow Directed Pacing CatheterNovember 22, 2016
K160260biotrace medicalTempo Temporary Pacing LeadOctober 25, 2016
K161249medtronicStreamline 6495 Bipolar Temporary Myocardial Pacing LeadAugust 19, 2016
K152784st jude medicalPacel Bipolar Pacing CathetersOctober 22, 2015
K152633edwards lifesciencesChandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing October 15, 2015
K140972medtronicUNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD,June 6, 2014
K072770oscorTEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)January 22, 2008
K042190medtronic vascularMODEL 6416 TEMPORARY PACING LEAD SYSTEMSeptember 7, 2004
K040812medtronic vascularDETECT SURGICAL PACING AND MAPPING TOOLSeptember 2, 2004
K033858european custom manufacturingTEMPORARY BIPOLAR MYOCARDIAL PACING WIREJuly 12, 2004
K032613peter m. rothenberg, m.dTEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICENovember 20, 2003