EnSite Precision Cardiac Mapping System v2.6
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201148 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 Precision Cardiac Mapping System v2.6 is a cardiac mapping system designed to help healthcare professionals create fast, high-density maps of any chamber of the heart. It includes the EnSite Precision Software Installation v2.6 and the EnSite LiveView Dynamic Display Software License.
The system is supplied by Abbott Medical and is intended for use in clinical settings under the supervision of qualified healthcare professionals. It is regulated under FDA 510(k) authorization with product code DQK and was determined to be substantially equivalent. The device is used in cardiovascular procedures and is associated with the CV advisory committee.
Frequently asked questions
What is the EnSite Precision Cardiac Mapping System used for?
It is used by healthcare professionals to create fast, high-density maps of any chamber of the heart during cardiovascular procedures. This helps in diagnosing and treating cardiac arrhythmias by providing detailed electrical activity visualization.
What components are included with this system?
The system includes the EnSite Precision Cardiac Mapping System v2.6 hardware, the EnSite Precision Software Installation v2.6, and the EnSite LiveView Dynamic Display Software License for dynamic real-time display of mapping data.
Who supplies this cardiac mapping system?
It is supplied by Abbott Medical, based in St. Paul, Minnesota, USA. The manufacturer is responsible for distribution and technical support for clinical users.
Is this device intended for single-use or reuse?
The device data does not specify whether it is single-use or reusable. It is intended for use in clinical settings under the supervision of qualified healthcare professionals, but reuse protocols would depend on institutional policy and manufacturer guidelines not detailed here.
What regulatory authorization does this device have?
It has FDA 510(k) authorization under product code DQK, with a traditional clearance type. The device was determined to be substantially equivalent, with a decision date of June 26, 2020, under K201148.
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: EnSite Precision Manuals and Resources | Abbott, EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software ..., EnSite Precision Cardiac Mapping System Product Overview | Abbott, EnSite Precision Cardiac Mapping System V2.6, EnSite Precision Software ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201148 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA 510(k) K201148 24 fields · synced Oct 1, 2026