PQ Bypass, Inc.

PQ Bypass, Inc. specializes in endovascular devices, primarily central and peripheral venous stent-grafts like the TORUS Stent Graft System and the ENDOCROSS Device. These are designed to treat venous obstructions or aneurysms. The company also produces single-use vascular guide-catheters, which assist in the precise placement of stent-grafts during medical procedures.

PQ Bypass, Inc. is headquartered in the United States. Since the company’s devices are manufactured domestically, they fall under U.S. regulatory frameworks, including the FDA’s oversight. The FDA classifies these devices as Class III, which requires premarket approval (PMA) due to their high-risk nature, ensuring rigorous evaluation before commercialization.

PQ Bypass, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparent tracking and identification of medical devices in the U.S., helping healthcare providers and regulators verify product details, compliance, and safety information.

The FDA categorizes PQ Bypass, Inc.’s stent-grafts and related endovascular devices as Class III because they are intended for life-sustaining or life-supporting uses, or because they present a potential unreasonable risk of illness or injury if they fail. This classification requires the highest level of regulatory scrutiny, including premarket approval (PMA), to ensure safety and effectiveness before these high-risk devices enter the market.

The Class III classification means PQ Bypass, Inc.’s devices undergo extensive premarket approval (PMA) reviews by the FDA, which includes clinical trials and rigorous testing to confirm safety and efficacy. This process ensures that only well-vetted devices reach patients, but it also means these devices are subject to stricter monitoring and reporting requirements once approved, helping maintain their performance and safety in clinical settings.