# K081225: Cardica Pas-Port Proximal Anastomosis System

- Pathway: 510(k) (Traditional)
- Applicant: Cardica, Inc.
- Decided: Sep 5, 2008 after 128 days
- Product code: FZP (Clip, Implantable)
- 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 K970793 (1997). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003446: Symmetry Aortic Clip System, St. Jude Medical Cardiovascular Group, Inc. (2001) Summary page 1.

## Most influential descendants
- K091017: Cardica Pas-Port Proximal Anastomosis System, Model FG-000001 (2009), 1 descendant of its own
- K202124: Aesculap PAS-Port Proximal Anastomosis System (2020), 0 descendants of its own

## Indications for use
The PAS-Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.

Source page: https://510kreport.com/device/K081225
Methodology: https://510kreport.com/methodology