Intact Vascular, Inc.

Intact Vascular, Inc. specialises in bare-metal peripheral artery stents. Their primary product, the Tack Endovascular System, comes in multiple catheter sizes (4F and 6F) and is designed to treat occlusive disease in peripheral arteries, such as those in the legs. The system covers a range of vessel diameters from 1.5mm to 8.0mm, depending on the specific variant.

Intact Vascular, Inc. is based in the United States. As a US-based manufacturer, its devices are subject to FDA regulations, including classification under the US medical device hierarchy. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US regulatory requirements.

Intact Vascular, Inc.’s devices are listed in two key regulatory registries: the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. These listings help ensure transparency and compliance with both US and EU medical device regulations, particularly for devices that may be marketed internationally.

Intact Vascular, Inc.’s devices are classified as either Class IIb or Class III under medical device regulations. The Tack Endovascular System falls into these categories due to its intended use in treating peripheral artery disease, which carries higher risk factors. Class III devices typically require premarket authorisation, while Class IIb devices follow general medical device regulations, depending on the jurisdiction.