Cleared Traditional

Bioptimal Bipolar Pacing Catheter

K242863 · Bioptimal International Pte. , Ltd. · Cardiovascular
Jun 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K242863 is an FDA 510(k) clearance for the Bioptimal Bipolar Pacing Catheter, a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Bioptimal International Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on June 15, 2025, 268 days after receiving the submission on September 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K242863 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2024
Decision Date June 15, 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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