WorkMate Claris System
FDA 510(k)Class II (US FDA 510(k))
by Abbott
Identifiers
- 510(k) Number
- K210392 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 WorkMate Claris System is a diagnostic computer designed for electrophysiology (EP) labs, enabling the collection, display, and storage of data from multiple sources. It integrates mapping, ablation, and patient monitoring functions to support cardiac arrhythmia diagnostics and treatment procedures, including atrial fibrillation (AFib).
This system is intended for use in clinical electrophysiology settings and is supplied as a reusable medical device. It is not classified as single-use and requires proper maintenance and calibration. The device holds FDA 510(k) clearance under K210392, with a special review designation under the Cardiovascular advisory committee. Sterility and MRI safety specifications are not detailed in the provided data.
Frequently asked questions
What types of cardiac procedures can the WorkMate Claris System support in an electrophysiology lab?
The WorkMate Claris System is designed to support diagnostics and treatment procedures for cardiac arrhythmias, including atrial fibrillation (AFib). It integrates mapping, ablation, and patient monitoring functions to collect, display, and store data from multiple sources during these procedures, enabling comprehensive EP lab workflows.
Is the WorkMate Claris System intended for single-use or reusable applications, and what maintenance is required?
The WorkMate Claris System is a reusable medical device, not intended for single-use. Since it is reusable, it requires proper maintenance and calibration to ensure accurate performance and reliability during electrophysiology procedures.
How is the WorkMate Claris System regulated, and what was the outcome of its FDA submission?
The WorkMate Claris System received FDA clearance through a 510(k) submission (K210392) under a special review designation by the Cardiovascular advisory committee. The device was determined to be substantially equivalent to a predicate, allowing it to enter the market with the stated regulatory pathway.
What kind of data integration capabilities does the WorkMate Claris System offer in an EP lab?
The WorkMate Claris System is engineered to integrate data from multiple sources, including mapping, ablation tools, and patient monitoring systems. This allows clinicians to simultaneously collect, display, and store critical information during cardiac arrhythmia diagnostics and treatment, improving workflow efficiency and decision-making.
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: PDF WorkMate Claris System - Sante, Electrophysiology | Abbott, MAUDE Adverse Event Report: Abbott Medical WorkMate¿ Claris¿ Amplifier ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210392 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA 510(k) K210392 24 fields · synced Sep 19, 2026