CorVascular Completes First FDA Inspection Since Receiving 510(k) Clearance
CorVascular Diagnostics, LLC is pleased to announce the successful completion of a U.S. Food and Drug Administration (FDA) inspection of its Minnetonka, Minnesota manufacturing facility. The inspection concluded with a classification of No Action Indicated (NAI) — the highest possible outcome — with zero Form 483 observations issued.
What This Means
FDA inspections classify outcomes into three tiers: No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). In an industry where Form 483 observations and warning letters are not uncommon, achieving NAI with zero observations is the best possible result.
Built Right from the Start
CorVascular's quality management system was purpose-built for compliance from day one. Rather than retrofitting legacy processes, the company designed its operations around current FDA requirements and industry best practices from the ground up. This approach extends to every aspect of the business, from how devices are designed and tested to how complaints are documented and how changes are controlled.
The VasoGuard V-Series received FDA 510(k) clearance (K233976) in July 2024 after completing comprehensive system-level certification testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), wireless immunity, and cybersecurity, all evaluated as a complete system including the device, touchscreen computer, mobile cart, and accessories.
VasoGuard display at CorVascular's Minnetonka, Minnesota facility
Designed and Manufactured in Minnesota
Every VasoGuard system is designed and manufactured at CorVascular's facility in Minnetonka, Minnesota. Keeping production in the United States allows for tighter quality control, faster innovation cycles, and direct oversight of every step in the manufacturing process. This commitment to domestic manufacturing is backed by an industry-leading 5-year bumper-to-bumper warranty and Minnesota-based technical support.
CorVascular's production and fulfillment area in Minnetonka, Minnesota
A Record That Speaks for Itself
Since receiving FDA clearance, CorVascular has maintained a spotless regulatory record: zero FDA warning letters, zero adverse event reports in the MAUDE database, and zero product recalls. The successful completion of this FDA inspection adds another milestone to that record and reinforces the trust that healthcare professionals place in the VasoGuard platform.
About Peripheral Arterial Disease
Peripheral Arterial Disease (PAD) affects approximately 6.5 million Americans over the age of 40 and more than 200 million individuals worldwide. Early detection through non-invasive vascular testing is critical to preventing progression to limb-threatening ischemia and amputation. CorVascular's VasoGuard V-Series provides healthcare professionals with accurate, reliable tools for PAD and PVD screening, diagnosis, and monitoring.
