510(k) K001926

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES by Thoratec Laboratories Corp. — Product Code DYB

K001926 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES". The FDA issued a decision of Substantially Equivalent on September 22, 2000. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.