# K040163: Microvascular Anastomotic Device

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Micro Companies Alliance, Inc.
- Decided: Apr 16, 2004 after 81 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861985 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861985: 3M Brand Microvascular Anastomotic Coupler (27XX), 3M Company (1986) Summary page 4.

## Most influential descendants
- K090679: Vesselink Microvascular Anastomotic Coupler System (2009), 0 descendants of its own

## Recalls of this device
- May 14, 2008 · Not classified · Z-2138-2008: Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.

## Indications for use
The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.

Source page: https://510kreport.com/device/K040163
Methodology: https://510kreport.com/methodology