Radical Catheter gets FDA clearance for 6F catheter
The 6F neurovascular access catheter is the company’s third FDA-cleared catheter and is designed for MMA embolization and radial access procedures.
Radical Catheter Technologies has received FDA 510(k) clearance for its 6F neurovascular access catheter. The Los Gatos, CA-based company is a NeuroTechnology Investors portfolio company.
FDA’s product-code database lists Radical 6F Access Catheter under 510(k) K253975. The device is classified as a Class II percutaneous catheter for neurovascular access.
Radical said the new catheter is its third FDA-cleared device. The company said the 6F broadens therapeutic options for middle-meningeal artery embolization and radial access procedures.
Built on patented ribbon technology, the catheter is designed to provide flexibility, push, stability, and durability while navigating complex anatomy, according to Radical.
A thinner wall construction provides a greater inner diameter relative to outer diameter. The platform also includes a smooth, continuous liner intended to support delivery of other therapeutic devices.
Radical plans to exhibit the catheter platform at the Society of NeuroInterventional Surgery’s 23rd Annual Meeting, scheduled for July 20-24 in Seattle.
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