Cleared Special

Medtronic Model 53401 External Pulse Generator (EPG)

K180873 · Medtronic, Inc. · Cardiovascular
Apr 2018
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K180873 is an FDA 510(k) clearance for the Medtronic Model 53401 External Pulse Generator (EPG), a Pulse-generator, Pacemaker, External (Class II — Special Controls, product code DTE), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 19, 2018, 16 days after receiving the submission on April 3, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.

Submission Details

510(k) Number K180873 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2018
Decision Date April 19, 2018
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTE — Pulse-generator, Pacemaker, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3600

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