Cook filter 510(k) nod
This article was originally published in The Gray Sheet
Executive Summary
Cook's Günther Tulip vena cava filter receives 510(k) clearance for use on a removable basis. Originally designed for both temporary and permanent use, the device captures blood clots before they can reach the lungs, causing a pulmonary embolism. Competitors include Cordis, B. Braun and Bard (1"The Gray Sheet" Aug. 18, 2003, p. 18)...