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AcQMap 3D Imaging and Mapping Catheter, Model 900009

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210766

by Acutus Medical, Inc.

Identifiers

510(k) Number
K210766 FDA 510(k)
FDA Product Code
MTD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1220 FDA 510(k)
Regulation Number
870.1220 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AcQMap 3D Imaging and Mapping Catheter, Model 900009, is a high-density array intracardiac mapping catheter designed for detailed three-dimensional electroanatomical mapping of cardiac structures. It provides precise spatial and electrical data to support diagnostic and interventional procedures in cardiovascular electrophysiology, enabling accurate visualization of cardiac anatomy and arrhythmogenic substrates.

This catheter is intended for single-use applications within the cardiac catheterization laboratory. It is supplied sterile and requires no additional sterilization before use. The device is classified as Class II under FDA regulations (870.1220) and has received FDA 510(k) clearance and MDR authorization. Multiple reference codes (e.g., 1721676, 3005334138) correspond to its regulatory submissions and product registrations.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acutus Medical, Inc.

Sources (2)

  • FDA 510(k) K210766 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026