Cleared Traditional

Temporary Cardiac Pacing Wire

K173923 · Ethicon, Inc. · Cardiovascular
Aug 2018
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K173923 is an FDA 510(k) clearance for the Temporary Cardiac Pacing Wire, a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 2, 2018, 219 days after receiving the submission on December 26, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K173923 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2017
Decision Date August 02, 2018
Days to Decision 219 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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