510(k) K021475

BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET by Bd — Product Code FMI

K021475 is an FDA 510(k) premarket notification submitted by Bd for the device "BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET". The FDA issued a decision of Substantially Equivalent on July 19, 2002. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Bd has at least 10 other 510(k) clearances on record.