(72 days)
The Paragonix SherpaPak™ Pediatric Liver Transport System is intended to be used for the static hypothermic preservation of pediatric donor livers or partial adult livers intended for pediatric recipients during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the livers. The intended organ storage time for the Paragonix SherpaPak™ Pediatric Liver Transport System is up to 15 hours.
Donor livers 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.
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This document is a 510(k) premarket notification for the Paragonix SherpaPak Pediatric Liver Transport System. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a notice of substantial equivalence rather than a detailed performance study report.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).