510(k) K020189

EXEL BUTTERFLY SCALP VEIN SET by Exelint International, Co. — Product Code FPA

K020189 is an FDA 510(k) premarket notification submitted by Exelint International, Co. for the device "EXEL BUTTERFLY SCALP VEIN SET". The FDA issued a decision of Substantially Equivalent on Mar 27, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Exelint International, Co. has at least 6 other 510(k) clearances on record.