Cleared Traditional

EnSite X EP System

K221213 · Abbott · Cardiovascular
Aug 2022
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K221213 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 (St. Paul, US). The FDA issued a Cleared decision on August 18, 2022, 113 days after receiving the submission on April 27, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K221213 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2022
Decision Date August 18, 2022
Days to Decision 113 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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