ClearStream Technologies , Ltd.

ClearStream Technologies, Ltd. specializes in devices for vascular and peripheral interventions, including over-the-wire (OTW) angioplasty balloon catheters (like the Sleek PTA Dilatation Catheter) for treating arterial blockages, non-medicated peripheral artery stent-grafts, single-use vascular guide-catheters (such as the Halo One™ Thin-Walled Guiding Sheath), and electrosurgical system generators. These products are designed to support procedures like angioplasty and vascular access, addressing common cardiovascular needs.

ClearStream Technologies, Ltd. is based in the United States, which means its devices fall under FDA jurisdiction. The company’s products are classified as either Class II or Class III, requiring regulatory submissions like 510(k) pre-market notifications or Unique Device Identifiers (UDIs) in the FDA’s UDI database. The U.S. location ensures compliance with FDA-specific pathways for device authorization.

ClearStream Technologies, Ltd.’s devices are recorded in the FDA’s 510(k) and UDI registries. The 510(k) database tracks submissions for Class II devices seeking equivalence to existing approved products, while the UDI system ensures traceability and transparency in the supply chain. These registries help healthcare providers verify device compliance and authorization status before use.

ClearStream Technologies, Ltd.’s devices are classified as either Class II or Class III under FDA regulations. Class II devices, like some angioplasty catheters, generally pose moderate risks and require special controls beyond general controls. Class III devices, such as certain stent-grafts or electrosurgical generators, are higher-risk and typically require pre-market approval (PMA) due to insufficient data from general or special controls alone, ensuring rigorous safety and effectiveness validation.