K242705

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 Unipolar Temporary Myocardial Pacing Lead (6500)

510(k) number
K242705
Device name
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 Unipolar Temporary Myocardial Pacing Lead (6500)
Applicant
Medtronic, Inc. MN · US
Product code
LDF — Electrode, Pacemaker, Temporary
Decision date
2025-01-17
Date received
2024-09-09
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K242705.pdf

Official FDA record: K242705
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.