Acrostak (Schweiz) AG

Acrostak (Schweiz) AG specialises in single-use vascular guide catheters and microcatheters. These devices are designed for interventional procedures, including diagnostic and therapeutic applications, where precise navigation within blood vessels is required. The portfolio includes flexible guide catheters and microcatheters tailored for use in complex vascular environments.

Acrostak (Schweiz) AG is headquartered in the United States. Its devices are authorised for commercial distribution in the US market, where they undergo regulatory review to ensure compliance with local requirements before being made available to healthcare providers.

Acrostak’s devices are classified as Class II medical devices under US regulations. This classification is determined by the FDA based on the level of risk associated with the device’s intended use. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, which aligns with the precision and clinical application of vascular guide catheters and microcatheters.

Acrostak’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. Inclusion in the 510(k) registry indicates that the devices have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. The UDI registry ensures traceability and transparency in the supply chain, allowing for better tracking of devices in clinical and commercial settings.