Ablamap System
FDA 510(k)Class II (US FDA 510(k))
by Ablacon Inc.
Identifiers
- 510(k) Number
- K230008 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 Ablamap System is an electrophysiology mapping system used to assist in the diagnosis of complex cardiac arrhythmias. It comprises several hardware elements, including an amplifier, cart, monitor, and a workstation containing proprietary mapping software. Signals are transmitted from a 64-electrode mapping basket catheter through the amplifier to the workstation for processing.
The system is supplied as a multi-component setup and is intended for use in clinical settings under the direction of qualified medical professionals. It is regulated under FDA 510(k) authorization with the product code DQK and was cleared under the traditional clearance pathway. The device is associated with the Cardiovascular review advisory committee and is manufactured by Ablacon, Inc., located in Denver, Colorado.
Frequently asked questions
What is the Ablamap System used for?
The Ablamap System is used to assist in the diagnosis of complex cardiac arrhythmias, providing a comprehensive mapping solution for clinical settings.
How is the Ablamap System supplied?
The system is supplied as a multi-component setup, including an amplifier, cart, monitor, and workstation with proprietary mapping software.
Is the Ablamap System intended for single-use or reuse?
The description does not explicitly state whether the system is for single-use or reuse, but it is intended for use in clinical settings under the direction of qualified medical professionals.
What regulatory pathway was used for the Ablamap System?
The Ablamap System was cleared under the traditional 510(k) clearance pathway with the product code DQK.
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: AccessGUDID - DEVICE: Ablamap® System (00860457001568), Ablacon Inc. - RevMed, Ablamap® System (K230008) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230008 | Class II | Active |
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Manufacturer
- Manufacturer
- Ablacon Inc.
- FDA Applicant
- Ablacon, Inc.
Sources (1)
- FDA 510(k) K230008 24 fields · synced Sep 23, 2026