510(k) K981076

VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT by Impra, Inc. — Product Code DYF

K981076 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT". The FDA issued a decision of Substantially Equivalent on May 7, 1998. The device falls under product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter), a Class II device regulated under 21 CFR 870.3450. Impra, Inc. has at least 10 other 510(k) clearances on record.