510(k) K011589

CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M by Bypass , Ltd. — Product Code NCA

K011589 is an FDA 510(k) premarket notification submitted by Bypass , Ltd. for the device "CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M". The FDA issued a decision of Substantially Equivalent on December 26, 2001. The device falls under product code NCA (Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)), a Class II device regulated under 21 CFR 878.4300. Bypass , Ltd. has at least 1 other 510(k) clearance on record.