NATEC MEDICAL LTD

Natec Medical Ltd specializes in over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheters. These devices are primarily used for vascular dilation in both peripheral and coronary arteries. The company’s portfolio includes catheters compatible with guidewires of 0.014", 0.018", and 0.035", catering to a range of interventional procedures.

Natec Medical Ltd is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing operations, and compliance with U.S. medical device regulations.

Natec Medical Ltd’s PTA balloon catheters fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) or other regulatory pathways.

Yes, Natec Medical Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details, such as manufacturer information and regulatory status.

The primary purpose of Natec Medical Ltd’s PTA balloon catheters is to dilate narrowed or blocked blood vessels in both peripheral arteries (e.g., legs) and coronary arteries (e.g., heart). These catheters are designed to be inserted over a guidewire and inflated to restore blood flow, improving circulation and treating conditions like peripheral artery disease (PAD) or coronary artery disease (CAD).