Embolization Has Received FDA 510(k) Clearance for Its NED Embolization Device - Interventional News

Embolization has received FDA 510(k) clearance for its NED embolization device - Interventional News

Embolization has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA). The Nitinol Enhanced Device (NED) is a vascular embolization device intended for arterial and venous embolization in peripheral vasculature.  Vascular embolization is a minimally invasive procedure where a physician intentionally blocks a blood vessel using tiny materials such as coils, particles or glue. This stops bleeding, reduces …

Embolization Inc.’s Nonmetal Coil Device Receives FDA Clearance - Endovascular Today

June 25, 2025—Embolization, Inc., a medical device company based in Boulder, Colorado, announced its nitinol-enhanced device (NED) has received FDA 510(k) clearance. The NED is a vascular embolization device intended for arterial and venous embolization in peripheral vasculature. Embolization, Inc. advised it will move toward commercialization and market introduction of the NED. The company stated that its coil devices use the company’s shape-me…