DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS

About This 510(k) Submission

K071196 is an FDA 510(k) clearance for the DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on September 6, 2007, 129 days after receiving the submission on April 30, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.