Endologix, Inc. - FDA 510(k) Cleared Devices

Endologix, Inc. is a vascular intervention company focused on delivering healthcare innovation for patients with vascular disease. The company operates with a manufacturing facility in Irvine, California, and specializes in Cardiovascular devices for endovascular repair and peripheral artery disease treatment.

Endologix has received 5 FDA 510(k) clearances from 5 total submissions since its first clearance in 1999. The company's regulatory portfolio is entirely focused on Cardiovascular devices, with its most recent clearance in 2012. This represents a historical regulatory record with no submissions in the past decade.

The company's cleared devices include introducer systems and dual lumen catheters designed for endovascular procedures. Endologix's product portfolio addresses unmet clinical needs in abdominal aortic aneurysm (AAA) repair and peripheral artery disease (PAD) treatment, supported by clinical evidence from multiple randomized controlled trials.

Explore the complete list of device names, product codes, and clearance dates in the FDA 510(k) database to review Endologix's full regulatory history.