Fusion Bioline Vascular Graft

The Fusion Bioline Vascular Graft is a single-use, permanent synthetic vascular graft designed to repair or replace peripheral arteries. It consists of two fused layers: an inner layer of expanded polytetrafluoroethylene (ePTFE) and an outer layer of knit polyester, bonded with a polycarbonate-urethane adhesive. The graft features a heparin and recombinant human albumin coating on its inner surface and includes optional external support coils.

The subject device shares the same two-layer design, fused adhesive construction, and Bioline coating as the predicate device. Modifications include a comparable outer layer and comparable adhesive formula. Both the subject and predicate devices use identical sterilization methods, packaging materials, shelf-life specifications, and are intended for the same patient population and anatomical sites.

Not stated in this summary.

The subject device demonstrates substantial equivalence because it has identical indications for use, the same operating principles, and the same fundamental design as the predicate Fusion Bioline Vascular Graft (K131778). Design verification and validation testing—including performance tests, biocompatibility tests, and user evaluation—showed no new or different safety or effectiveness concerns. The minor modifications to the outer layer and adhesive do not raise new questions regarding safety or effectiveness.