510(k) K971192

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT by Impra, Inc. — Product Code DSY

K971192 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT". The FDA issued a decision of ST on April 15, 1997. 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.