Cleared Traditional

Rotatable Connector (5944RL)

K241199 · Shenzhen Launch Electrical Co., Ltd. · Cardiovascular
Jan 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K241199 is an FDA 510(k) clearance for the Rotatable Connector (5944RL), a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Shenzhen Launch Electrical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 23, 2025, 268 days after receiving the submission on April 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K241199 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2024
Decision Date January 23, 2025
Days to Decision 268 days
Submission Type Traditional
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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