510(k) K962639

IMPRA CARBOFLO EPTFE VASCULAR GRAFT by Impra, Inc. — Product Code DSY

K962639 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "IMPRA CARBOFLO EPTFE VASCULAR GRAFT". The FDA issued a decision of SESP on October 3, 1996. 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.