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FDA 510(k)

SherpaPak Pediatric Liver Transport System

K-Number: K201048 · 2020-07-02

ApplicantParagonix Technologies
Decision Date2020-07-02
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SherpaPak Pediatric Liver Transport System is a medical device manufactured by Paragonix Technologies. It received FDA 510(k) clearance on 2020-07-02 under approval number K201048. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SherpaPak Pediatric Liver Transport System?

SherpaPak Pediatric Liver Transport System is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by Paragonix Technologies. The 510(k) number is K201048.

When was SherpaPak Pediatric Liver Transport System approved by the FDA?

SherpaPak Pediatric Liver Transport System received FDA 510(k) clearance on 2020-07-02, under approval number K201048.

What company makes SherpaPak Pediatric Liver Transport System?

SherpaPak Pediatric Liver Transport System is manufactured by Paragonix Technologies.

What is the FDA product code for SherpaPak Pediatric Liver Transport System?

The FDA product code for SherpaPak Pediatric Liver Transport System is KDN.

Related Clinical Trials

NCT07578441 VitaSmart HOPE System: Bridge to HOPE Registry ENROLLING_BY_INVITATION NCT06486454 Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT03775980 CIRSE Emprint Microwave Ablation Registry COMPLETED NCT05574361 Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Paragonix Technologies

K182735Paragonix SherpaPak Cardiac Transport System K191440Paragonix SherpaPak Pancreas Transport System K223874BAROguard K234060KIDNEYvault Portable Renal Perfusion System

Related Devices (Code: KDN)

K153384Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation K180481Servator B SALF SolutionS.A.L.F. Spa K170826Perfadex PlusXvivo Perfusion AB K191440Paragonix SherpaPak Pancreas Transport SystemParagonix Technologies K191006EasiSlushBridge TO Life, Ltd. K192869SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemPragonix Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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