Volta Medical

Volta Medical specializes in electrophysiology mapping systems, specifically the VX1+ and VX1. These devices are designed for cardiac electroanatomical mapping and ablation procedures, utilizing 3D mapping technology to help visualize heart structures and guide catheter-based treatments.

Volta Medical is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational base, particularly when reviewing compliance or device listings.

Volta Medical’s devices, including the VX1+ and VX1, are classified as Class II under FDA regulations. This classification is determined by the device’s intended use and risk level, with Class II requiring special controls to ensure safety and effectiveness beyond general controls.

Volta Medical’s devices are listed under the FDA’s 510(k) clearance pathway. This pathway is used for demonstrating that a new device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA requirements before commercial distribution.