CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU

About This 510(k) Submission

K020316 is an FDA 510(k) clearance for the CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on March 20, 2002, 49 days after receiving the submission on January 30, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.