What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices.

Abstract

In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received Food and Drug Administration (FDA) approval to begin marketing the WavelinQ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ EndoAVF System was of "substantial equivalence" to the WavelinQ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they w