Cleared Traditional

EnSite? X EP System

K252013 · Abbott Medical · Cardiovascular
Sep 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K252013 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 September 25, 2025, 90 days after receiving the submission on June 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K252013 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date September 25, 2025
Days to Decision 90 days
Submission Type Traditional
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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