MicroVention, Inc. - FDA 510(k) Cleared Devices

MicroVention, Inc., now operating as Terumo Neuro, is a neuroendovascular medical device company headquartered in Aliso Viejo, California. The company develops and commercializes catheter-based, minimally invasive technologies for treating neurovascular disorders including hemorrhagic stroke, ischemic stroke, carotid artery disease, and neurovascular malformations.

MicroVention has maintained a strong FDA 510(k) regulatory record since its first clearance in 2001. The company has received 85 FDA 510(k) clearances from 85 total submissions, with no denied submissions. The latest clearance was issued in 2024, demonstrating continued active development and regulatory engagement in neurology devices.

The company's product portfolio spans multiple access and therapeutic categories. Recent FDA 510(k) cleared devices include delivery catheters, intracranial support catheters, neurovascular navigation catheters, retrieval devices, balloon guide catheters, guidewires, microcatheters, and occlusion balloon catheters. These products are designed to enable minimally invasive endovascular procedures and support treatment delivery across hemorrhagic and ischemic stroke indications.

Founded in 1997 and acquired by Terumo Corporation in 2006, the company operates as part of a global organization with over 3,800 employees. Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.

2 devices have linked clinical trials registered on ClinicalTrials.gov.