# K090679: Vesselink Microvascular Anastomotic Coupler System

- Pathway: 510(k) (Traditional)
- Applicant: Vioptix, Inc.
- Decided: Apr 17, 2009 after 32 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- 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: 2 generations back to K861985 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040163: Microvascular Anastomotic Device, Synovis Micro Companies Alliance, Inc. (2004) Summary page 1.

## Indications for use
The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.

Source page: https://510kreport.com/device/K090679
Methodology: https://510kreport.com/methodology