Cleared Traditional

TME Temporary Myocardial Electrode

K232261 · Osypka AG · Cardiovascular
Apr 2024
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K232261 is an FDA 510(k) clearance for the TME Temporary Myocardial Electrode, a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Osypka AG (Rheinfelden, DE). The FDA issued a Cleared decision on April 26, 2024, 270 days after receiving the submission on July 31, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K232261 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2023
Decision Date April 26, 2024
Days to Decision 270 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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