Dib Ultranav Medical, LLC

Dib Ultranav Medical, LLC specializes in cardiac transseptal access sets. Their main product, the Dib UltraNav Transseptal Catheter System, is specifically designed to assist in guiding catheters across the atrial septum during procedures like ablation or valve repair. This focus ensures their devices are tailored for precise and controlled access in cardiac interventions.

Dib Ultranav Medical, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the FDA’s device classification system. This means their products must comply with U.S. regulatory requirements, such as those outlined in the FDA’s 510(k) and Unique Device Identifier (UDI) databases.

Dib Ultranav Medical, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices, allowing healthcare providers, regulators, and other stakeholders to access critical information about the company’s products, including their regulatory status and compliance.

Dib Ultranav Medical, LLC’s devices fall under FDA Class II classification. This classification indicates that while the devices are not considered high-risk, they still require special controls to ensure their safety and effectiveness. Class II devices undergo rigorous review processes, including 510(k) premarket submissions, to demonstrate compliance with performance standards and regulatory requirements before they can be marketed.