Embolic Acceleration, LLC

Embolic Acceleration, LLC specializes in metallic embolization plugs, specifically designed for non-neurovascular embolization procedures. Their primary focus is on devices like the Hourglass Peripheral Embolization Device and its variations, which are intended to occlude blood vessels in peripheral areas of the body. These devices are engineered to stop blood flow in targeted vessels, often used in interventional radiology or vascular surgery.

Embolic Acceleration, LLC is based in the United States. As a US-based manufacturer, its devices are subject to the regulatory requirements outlined by the US Food and Drug Administration (FDA). The company develops its products in compliance with applicable US medical device regulations, ensuring they meet safety, performance, and quality standards.

Embolic Acceleration, LLC’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for medical devices authorized for use in the US market, helping healthcare providers and regulators verify device details and authorization status.

Embolic Acceleration, LLC’s embolization plugs fall under Class II classification in the US regulatory system. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device before being authorized for sale.