# K143074: Sherpa Pak Cardiac Transport System

- Pathway: 510(k) (Special)
- Applicant: Paragonix Technologies, Inc.
- Decided: Nov 25, 2014 after 29 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883782 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133432: Sherpa Pak Cardiac Transport System, Paragonix Technologies, Inc. (2014) Summary page 6.
- K991594: Celsior Cold Flush, Storage and Transport Solution for Hearts, Sangstat Medical Corp. (1999) Summary page 6.
- K032794: Custodiol, Dr. Franz Kohler Chemie GmbH (2004) Summary page 6.

## Indications for use
The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Source page: https://510kreport.com/device/K143074
Methodology: https://510kreport.com/methodology