SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands

About This 510(k) Submission

K212977 is an FDA 510(k) clearance for the SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Cordis Corporation (Miami Lakes, US). The FDA issued a Cleared decision on February 17, 2022, 153 days after receiving the submission on September 17, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.