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The CorLink AAS is indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG). The Coring punch component penetrates the aorta and cuts a circumferential aortotomy in which the implanted device will be deployed.

This 510(k) notification describes the CorLink™ Automated Anastomotic Device indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting. The Coring punch device is intended for creating the aortotomy in which the implanted device will be deployed. The major differences between the two systems are: 1. The Piercing Tip and the Tissue Grabber are in one piece in the modified coring punch 2. Tissue Grabber button was replaced by an automatic Tissue Grabber activation button component 3. The Tissue Grabber in the modified coring punch contains 3 barbs instead of 2 as in the 510k cleared coring punch design 4. The Cylinder Cutting Edge diameter will range from 2.5 mm to 3.6 mm and from 2.9 mm to 4.0 mm in the 2.0 mm and 4.0 mm size kits (in 0.1 mm increments each), respectively. 5. The modified coring punch is single use only, whereas the 510(k) cleared coring punch was for single patient use.