# K033979: Corlink Automated Anastomotic System

- Pathway: 510(k) (Traditional)
- Applicant: By-Pass Makafim, Ltd.
- Decided: Mar 31, 2004 after 99 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864146 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020470: Modification to Corlink Automated Anastomotic Device, Bypass, Ltd. (2002) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K033979
Methodology: https://510kreport.com/methodology