510(k) K984183

PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 by Possis Medical, Inc. — Product Code DYF

K984183 is an FDA 510(k) premarket notification submitted by Possis Medical, Inc. for the device "PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451". The FDA issued a decision of Substantially Equivalent on February 1, 1999. 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. Possis Medical, Inc. has at least 10 other 510(k) clearances on record.