510(k) K071196

DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS by Coeur, Inc. — Product Code DQO

K071196 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS". The FDA issued a decision of Substantially Equivalent on September 6, 2007. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Coeur, Inc. has at least 10 other 510(k) clearances on record.