2mg, Inc.

2mg, Inc. specializes in the ROVO Mechanical Thrombectomy Device, which is specifically designed for removing blood clots from blood vessels. This device is primarily used in medical procedures to treat conditions like stroke and peripheral artery disease, where clot removal is critical to restoring blood flow.

2mg, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US medical device standards.

The ROVO Mechanical Thrombectomy Device, manufactured by 2mg, Inc., is classified as a Class II medical device under US regulations. This classification indicates a moderate level of risk and requires compliance with specific controls to ensure safety and effectiveness, including performance testing and post-market surveillance.

The ROVO Mechanical Thrombectomy Device is listed under the FDA’s 510(k) pathway, meaning it has undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. This registration is publicly accessible in the FDA’s database, allowing healthcare providers and regulators to verify compliance and device details.