510(k) K915168

PROFLEX 5 by Peripheral Systems Group — Product Code LIT

K915168 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "PROFLEX 5". The FDA issued a decision of Substantially Equivalent on February 19, 1992. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Peripheral Systems Group has at least 10 other 510(k) clearances on record.