510(k) K003627

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET by Exelint International, Co. — Product Code FMI

K003627 is an FDA 510(k) premarket notification submitted by Exelint International, Co. for the device "EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET". The FDA issued a decision of Substantially Equivalent on February 8, 2001. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Exelint International, Co. has at least 6 other 510(k) clearances on record.