Cleared Special

Medtronic Model 5392 External Pulse Generator (EPG)

K181973 · Medtronic, Inc. · Cardiovascular
Aug 2018
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K181973 is an FDA 510(k) clearance for the Medtronic Model 5392 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 August 21, 2018, 28 days after receiving the submission on July 24, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.

Submission Details

510(k) Number K181973 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2018
Decision Date August 21, 2018
Days to Decision 28 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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