510(k) K004011

IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS by Impra, Inc. — Product Code DSY

K004011 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS". The FDA issued a decision of Substantially Equivalent on March 27, 2001. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Impra, Inc. has at least 10 other 510(k) clearances on record.