# K063644: Cardica C-Port XA Distal Anastomosis System

- Pathway: 510(k) (Special)
- Applicant: Cardica, Inc.
- Decided: Jan 11, 2007 after 35 days
- Product code: FZP (Clip, Implantable)
- 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: 11 generations back to K933887 (1993). 34 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053524: C-Port Distal Anastomosis System, Cardica, Inc. (2006) Summary page 1.
- K040832: C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050, Cardica, Inc. (2005) Summary page 1.

## Most influential descendants
- K090872: Modification to Cardica C-Port XA Distal Anastomosis System (2009), 1 descendant of its own
- K070548: C-Port Flexa Distal Anastomosis System (2007), 1 descendant of its own
- K101018: Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100 (2010), 0 descendants of its own
- K073304: Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change Subassemblies (2007), 0 descendants of its own
- K073123: Cardica C-Port Flex-a Distal Anastomosis System, Model FG-000150 (2007), 0 descendants of its own

## Recalls of this device
- Apr 2, 2018 · Class II · Z-2433-2018: Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.

## Indications for use
The Cardica C-Port® xA Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.

Source page: https://510kreport.com/device/K063644
Methodology: https://510kreport.com/methodology