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EnSite X EP System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252013

by Abbott Medical

Identifiers

510(k) Number
K252013 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EnSite X EP System is an electrophysiological (EP) mapping device classified as a Cardiac Mapping System under the FDA’s nomenclature. It provides real-time, three-dimensional visualization of cardiac electrical activity and catheter positioning, enabling precise mapping and ablation guidance during procedures.

This system is intended for use in electrophysiology laboratories, where it supports conventional EP procedures by delivering detailed anatomical and electrical data. Supplied as a reusable medical device, it is designed for sterile use per procedural protocols and adheres to MRI safety standards as defined by the manufacturer. Authorized under FDA 510(k) clearance (K252013), it operates under traditional review pathways within the Cardiovascular advisory committee.

Frequently asked questions

What types of electrophysiology procedures can the EnSite™ X EP System support in the lab, and how does it help guide interventions?

The EnSite™ X EP System is designed for conventional electrophysiology (EP) procedures, providing real-time, three-dimensional visualization of cardiac electrical activity and catheter positioning. This detailed anatomical and electrical data helps clinicians map arrhythmias, guide ablation therapies, and improve precision during interventions like catheter ablation for atrial fibrillation or ventricular tachycardia.

Is the EnSite™ X EP System intended for single-use or reusable applications, and how should it be prepared for sterile use?

The EnSite™ X EP System is a reusable medical device, but it must be prepared for sterile use according to procedural protocols during each procedure. While it is not disposable, its design ensures compatibility with sterile field requirements in the electrophysiology lab, allowing repeated use across multiple cases with proper cleaning and maintenance.

Does the EnSite™ X EP System have any specific safety considerations related to MRI environments, and how does it comply with manufacturer guidelines?

Yes, the EnSite™ X EP System adheres to MRI safety standards as defined by the manufacturer. This means it is designed to be used safely in environments where MRI compatibility is required, ensuring that the device does not interfere with imaging or pose risks during concurrent procedures. Always follow the manufacturer’s guidelines for MRI-safe use.

How was the FDA clearance for the EnSite™ X EP System determined, and which advisory committee was involved in the review process?

The EnSite™ X EP System received FDA clearance under the 510(k) pathway (K252013) through a traditional review process, determined to be *substantially equivalent* to a predicate device. The review was conducted under the Cardiovascular (CV) advisory committee, which evaluates cardiovascular-related medical devices for safety and effectiveness before clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About EnSite X EP System | Abbott, Cardiac Mapping Systems | Abbott, Introducing: EnSite™ X Software Version 3 | Abbott, Cardiac Mapping Equipment | EnSite Precision | EnSite™ X EP

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA 510(k) K252013 24 fields · synced Sep 19, 2026