510(k) K880877

CONTRAST INJECTION DEVICE by Med-West, Inc. — Product Code DXT

K880877 is an FDA 510(k) premarket notification submitted by Med-West, Inc. for the device "CONTRAST INJECTION DEVICE". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Med-West, Inc. has at least 10 other 510(k) clearances on record.