# K101018: Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100

- Pathway: 510(k) (Special)
- Applicant: Cardica, Inc.
- Decided: Jun 25, 2010 after 73 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: 13 generations back to K933887 (1993). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090872: Modification to Cardica C-Port XA Distal Anastomosis System, Cardica, Inc. (2009) Summary page 1.

## 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 Plus Distal 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/K101018
Methodology: https://510kreport.com/methodology