CorLink Automated Anastomotic System
by By-Pass Makafim, Ltd. 510(k)
Active
510(k) K033979
Overview
The CorLink Automated Anastomotic System is a surgical device classified as an implantable clip designed to facilitate the creation of vascular anastomoses. It is specifically engineered to connect a venous graft conduit to the aorta during coronary artery bypass grafting (CABG) procedures. The system includes a coring punch component that penetrates the aorta and excises a circumferential segment for device deployment, ensuring precise and secure attachment of the graft.
This device is intended for use in the operating room during cardiac surgery, where sterile techniques are mandatory. It is supplied as a single-use, implantable system and must be handled in accordance with standard surgical protocols. The system is regulated under FDA 510(k) clearance (K033979) and is categorized under product code FZP, adhering to the regulatory requirements for implantable vascular devices. No MRI safety information or reusable components are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033979 | Date31 Mar 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FZP
- FDA applicant
- By-Pass Makafim , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the CorLink Automated Anastomotic System used for?
The CorLink Automated Anastomotic System is designed specifically for creating vascular anastomoses during coronary artery bypass grafting (CABG). It connects a venous graft conduit to the aorta by excising a precise circumferential segment of the aorta, allowing for secure and automated attachment of the graft. This reduces manual complexity and improves consistency in the operating room.
How is the CorLink Automated Anastomotic System supplied and handled?
The system is supplied as a single-use, implantable device. It must be handled under sterile conditions in the operating room, adhering to standard surgical protocols. The coring punch component is part of the system and is intended for one-time use only, ensuring patient safety and preventing cross-contamination.
Is the CorLink Automated Anastomotic System reusable?
No, the CorLink Automated Anastomotic System is explicitly designed for single-use only. This design choice aligns with surgical best practices for implantable devices to minimize infection risks and ensure reliability during critical procedures like CABG.
What regulatory approval does the CorLink Automated Anastomotic System hold?
The CorLink Automated Anastomotic System has received FDA 510(k) clearance under the product code FZP, which categorizes it as an implantable vascular device. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory requirements for surgical implants.
How does the CorLink Automated Anastomotic System differ from manual anastomosis techniques?
The CorLink system automates the process of creating anastomoses by using a coring punch to excise a precise segment of the aorta, eliminating the need for manual suturing or stapling. This reduces operator fatigue, improves precision, and standardizes the attachment of venous grafts to the aorta during CABG, potentially shortening procedure time and enhancing outcomes.