Arch Catheter LLC

Arch Catheter LLC specializes in intravascular occluding balloon catheters designed for image-guided procedures. These devices are specifically engineered to selectively occlude blood vessels, such as those in the aortic arch, during treatments like embolization or occlusion therapy. The company’s portfolio includes products like the ArchCath and Gatekeeper Balloon Catheter, which provide targeted vascular control during clinical interventions.

Arch Catheter LLC is headquartered in the United States. Its devices are intended for use within the US market, where they are regulated by the FDA. The company’s focus is on manufacturing intravascular occluding balloon catheters tailored for procedures requiring precise vascular occlusion.

Arch Catheter LLC’s devices fall under FDA Class II regulation. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness. The company’s products, such as the ArchCath and Gatekeeper Balloon Catheter, are subject to these regulatory standards to maintain their performance and safety in clinical applications.

Arch Catheter LLC’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. The 510(k) process ensures that the devices meet regulatory requirements by demonstrating substantial equivalence to legally marketed predicate devices, while the UDI system provides a standardized method for identifying medical devices throughout their distribution and use.