FDA.reportPublic FDA data

510(k) K242705

Device
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipo
Applicant
Medtronic, Inc.
510(k) number
K242705
Product code
LDF
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-17
Date received
2024-09-09
Regulation
870.3680
Classification name
Electrode, Pacemaker, Temporary
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Debra Taitague
Address
710 Medtronic Pkwy. Miinneapolis MN US 55432 55432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LDF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.2025-06-15
K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.2025-05-15
K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.2025-01-31
K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.2025-01-23
K232261TME Temporary Myocardial ElectrodeOsypka AG2024-04-26
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 LeadMedtronic2019-08-08
K173923Temporary Cardiac Pacing WireETHICON, Inc.2018-08-02
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 LeadMedtronic2017-05-25
K161873Pacel Flow Directed Pacing CatheterSt Jude Medical2016-11-22
K160260Tempo Temporary Pacing LeadBiotrace Medical, Inc.2016-10-25
K161249Streamline 6495 Bipolar Temporary Myocardial Pacing LeadMedtronic2016-08-19
K152784Pacel Bipolar Pacing CathetersSt Jude Medical2015-10-22
K152633Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeEdwards Lifesciences, LLC2015-10-15
K140972UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACINGMedtronic, Inc.2014-06-06
K072770TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)Oscor, Inc.2008-01-22