# K202124: Aesculap PAS-Port Proximal Anastomosis System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Sep 2, 2020 after 33 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K970793 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091017: Cardica Pas-Port Proximal Anastomosis System, Model FG-000001, Cardica, Inc. (2009) Summary page 4.

## Recalls of this device
- Apr 16, 2021 · Class II · Z-2578-2021: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
- Apr 16, 2021 · Class II · Z-2579-2021: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

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

Source page: https://510kreport.com/device/K202124
Methodology: https://510kreport.com/methodology