Cleared Special

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)

K242705 · Medtronic, Inc. · Cardiovascular
Jan 2025
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K242705 is an FDA 510(k) clearance for the 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), a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Medtronic, Inc. (Minneapolis,, US). The FDA issued a Cleared decision on January 17, 2025, 130 days after receiving the submission on September 9, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K242705 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2024
Decision Date January 17, 2025
Days to Decision 130 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LDF — Electrode, Pacemaker, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3680

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