Vascugenix, LLC

Vascugenix, LLC specializes in single-use vascular guide-catheters. These devices are primarily used to assist in guiding and positioning catheters within blood vessels during vascular interventions, such as angioplasty or stent placement. The company’s focus is on procedural support tools designed for precision and reliability in interventional cardiology.

Vascugenix, LLC is based in the United States. Since the company’s devices fall under FDA jurisdiction, they are subject to U.S. regulatory requirements. The FDA classifies these devices as Class II, which means they undergo specific controls to ensure safety and effectiveness before being listed in the FDA’s Unique Device Identifier (UDI) database.

Vascugenix, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers, regulators, and patients. The inclusion in this database reflects compliance with FDA requirements for device identification and reporting.

Vascugenix, LLC’s vascular guide-catheters are classified as FDA Class II devices. This classification indicates that while they pose moderate risks, they require special controls beyond general controls to ensure their safety and performance. The classification influences the regulatory pathway, including pre-market submissions, post-market surveillance, and labeling requirements, ensuring that these devices meet established standards for use in vascular procedures.