Radical Catheter gains FDA clearance for 6F access device
The 6F neurovascular access catheter is the company’s 3rd FDA-cleared catheter and is designed to broaden options for middle meningeal artery embolization and radial access procedures.
Radical Catheter Technologies has received U.S. Food and Drug Administration 510(k) clearance for its 6F neurovascular access catheter. The device is the company’s 3rd FDA-cleared catheter.
The 6F catheter is designed to broaden treatment options for middle meningeal artery embolization and radial access procedures. It is built on Radical’s ribbon technology platform, which the company said is designed to provide flexibility, push, and stability.
A thinner wall construction gives the catheter a larger inner diameter relative to outer diameter, according to the company. Radical said the design is intended to support more reliable device delivery in neurovascular procedures.
Earlier clearances include the company’s 7F and 8F neurovascular guide catheters. FDA records identify the 7F device as a percutaneous neurovascular catheter, cleared under 510(k) number K231393.
Radical’s 8F neurovascular catheter received FDA clearance in January 2025 and was described at the time as the company’s 2nd clearance for its ribbon technology platform.
Radical Catheter Technologies is a NeuroTechnology Investors portfolio company focused on endovascular access and delivery products. Its public product page lists the 7F and 8F guide catheters as FDA cleared, although the page had not yet been updated to include the 6F clearance when checked.
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