Cleared Traditional

EnSite? X EP System

K251234 · Abbott Medical · Cardiovascular
Jul 2025
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K251234 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 July 30, 2025, 99 days after receiving the submission on April 22, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K251234 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2025
Decision Date July 30, 2025
Days to Decision 99 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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