Cleared Special

EnSite? X EP System

K242016 · Abbott Medical · Cardiovascular
Aug 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242016 is an FDA 510(k) clearance for the EnSite? X EP System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on August 9, 2024, 30 days after receiving the submission on July 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K242016 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2024
Decision Date August 09, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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