Innova Vascular, Inc.

Innova Vascular, Inc. specializes in thrombectomy devices, which are used to remove blood clots from blood vessels. Their primary products include aspiration catheter systems, such as the Malibu Aspiration Catheter System, and wire-net clot retrieval systems, like the Laguna Clot Retriever System. These devices are designed for interventional radiology and cardiology procedures, particularly in treating conditions like stroke and peripheral artery disease.

Innova Vascular, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.

Innova Vascular, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These pathways ensure that the devices meet applicable regulatory requirements before being authorised for use.

Innova Vascular, Inc.’s thrombectomy devices fall under Class II classification by the FDA. This classification indicates that the devices pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices are authorised through pathways like the 510(k), which demonstrates substantial equivalence to a legally marketed predicate device.