Cleared Special

Bard? Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)

K251186 · C.R. Bard, Inc. · Cardiovascular
May 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251186 is an FDA 510(k) clearance for the Bard? Temporary Pacing Electrode Catheter Needle / Cannula (Introducer), a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 15, 2025, 29 days after receiving the submission on April 16, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K251186 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2025
Decision Date May 15, 2025
Days to Decision 29 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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