Atrion Medical Products, Inc.

Atrion Medical Products, Inc. specializes in single-use medical devices, specifically catheter and overtube balloon inflators for procedures like endoscopic and biliary dilation. They also produce disposable angiographic syringes designed for precise fluid delivery in clinical settings. These devices are tailored for controlled inflation and fluid management in demanding medical applications.

Atrion Medical Products, Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the company manufactures products like balloon inflators and angiographic syringes, these are classified under FDA categories such as Class I, Class II, and Unclassified (U), requiring compliance with U.S. medical device regulations. The FDA tracks these devices through submissions like 510(k), PMA, and UDI registrations.

Atrion Medical Products, Inc.’s devices are recorded in U.S. regulatory databases managed by the FDA, including the 510(k) premarket notification process for Class II devices, PMA (Premarket Approval) submissions for higher-risk devices, and UDI (Unique Device Identification) registrations. These systems ensure traceability and compliance tracking for devices like balloon inflators and syringes.

Atrion Medical Products, Inc.’s devices are classified under FDA categories Class I, Class II, and Unclassified (U). This classification determines the regulatory pathway and scrutiny required. For example, Class II devices (like some balloon inflators) undergo 510(k) clearance to demonstrate substantial equivalence to existing approved products, while Unclassified (U) devices may require additional review depending on their risk profile. The classification ensures appropriate oversight based on the device’s potential risk to patients.