Simpson Interventions, Inc.

Simpson Interventions, Inc. specializes in peripheral vascular intervention infusion catheters. These devices are specifically designed for delivering therapeutic agents directly into blood vessels during vascular procedures, ensuring precise and controlled treatment delivery. The company’s focus is on improving outcomes in interventional cardiology and vascular medicine.

Simpson Interventions, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under the agency’s risk-based system. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, which are publicly accessible registries for tracking medical devices authorized for commercial distribution in the U.S.

The devices produced by Simpson Interventions, Inc., such as the Shadow Catheter™ and its variants, are classified as Class II under FDA regulations. This classification is determined by the agency based on the device’s intended use and associated risks. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, and they are subject to premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device.

The devices manufactured by Simpson Interventions, Inc. are included in two key FDA registries: the 510(k) database and the Unique Device Identifier (UDI) database. The 510(k) registry tracks devices that have undergone premarket notification submissions to demonstrate compliance with FDA requirements, while the UDI database provides standardized identification for devices in the U.S. marketplace, ensuring traceability and transparency in the supply chain.

The FDA’s 510(k) and UDI systems serve distinct but complementary purposes in regulating medical devices. The 510(k) process ensures that Class II devices like those from Simpson Interventions meet safety and effectiveness standards by comparing them to a legally marketed predicate device. The UDI system, meanwhile, assigns a unique identifier to each device to improve tracking, reduce medical errors, and enhance post-market surveillance. Listing in both systems reflects the company’s compliance with U.S. regulatory requirements for device authorization and traceability.