FDA.reportPublic FDA data

510(k) K241199

Device
Rotatable Connector (5944RL)
Applicant
Shenzhen Launch Electrical Co., Ltd.
510(k) number
K241199
Product code
LDF
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-23
Date received
2024-04-30
Regulation
870.3680
Classification name
Electrode, Pacemaker, Temporary
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christina Zheng
Address
Bldg. F, Zhonggangxing Industrial Estate Zhangge Community Guanian St., Longhua New District Shenzhen CN 518110 518110

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
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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
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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