Acorys Mapping System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ACORYS EUDAMED
- Device Name
- ACORYS MAPPING SYSTEM EUDAMED
- Model / Reference
- ACORYS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435723404019 EUDAMED
- Basic UDI-DI
- 84357234ACORYSNT EUDAMED
- Direct Marketing DI
- 08435723404019 EUDAMED
- 510(k) Number
- K253861 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Acorys Mapping System is an electroanatomical mapping device designed for intracardiac visualization and navigation during cardiac procedures. It provides real-time 3D mapping of cardiac chambers and structures, enabling precise localization of arrhythmias and guiding ablation therapies for conditions such as atrial fibrillation, ventricular tachycardia, and other complex arrhythmias.
This system is intended for use in clinical electrophysiology laboratories by trained medical professionals. Supplied as a reusable device with FDA 510(k) clearance and MDR compliance, it integrates with existing cardiac electrophysiology equipment. The system requires proper calibration and maintenance as per manufacturer guidelines, and its use is governed by applicable regulatory standards for medical imaging and electrophysiological devices.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253861 | Class II | Active |
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Manufacturer
- Manufacturer
- Corify Care S.L
Sources (2)
- FDA 510(k) K253861 24 fields · synced Sep 18, 2026
- EUDAMED 0427add6-9e51-4d01-b9f1-25b77be2cc45 61 fields · synced Jul 10, 2026