Irras USA

Irras USA specializes in devices for intracranial pressure monitoring and cerebrospinal fluid management. Their portfolio includes short-term intracerebral sensor catheters, gravity-flow pressure regulation systems, cranial-fixation kits for surgical access, and patient monitoring modules for intracranial pressure. These devices are primarily designed for neurosurgical applications, such as monitoring brain pressure and managing fluid drainage.

Irras USA is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, including those governing medical device classification and reporting requirements.

Irras USA’s devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards, labeling requirements, or post-market surveillance. Class II devices typically require premarket notification (510(k)) clearance before commercial distribution.

Irras USA’s devices are listed in the FDA’s 510(k) database (for premarket notifications) and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency in device identification, compliance tracking, and post-market monitoring. The UDI system helps healthcare providers and regulators verify device details, such as manufacturer information and regulatory status.

Devices like the IRRAflow® Drainage Collection System and Hummingbird® Cranial Access Kit are designed for neurosurgical procedures. The drainage system manages cerebrospinal fluid (CSF) by regulating pressure and collecting excess fluid, reducing complications like swelling or infection. The cranial access kit provides precise surgical access to the brain, ensuring stable catheter placement for monitoring or infusion/drainage purposes. Both are critical for treating conditions like traumatic brain injury or hydrocephalus.