Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SherpaPak Lung Preservation System , SherpaPak Liver Transport System

K-Number: K192869 · 2020-01-16

ApplicantPragonix Technologies
Decision Date2020-01-16
Product CodeKDN
Advisory CommitteeGU
DecisionUnknown

Device Summary

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is a medical device manufactured by Pragonix Technologies. It received FDA 510(k) clearance on 2020-01-16 under approval number K192869. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is a medical device that received FDA 510(k) clearance on 2020-01-16. It is manufactured by Pragonix Technologies. The 510(k) number is K192869.

When was SherpaPak Lung Preservation System , SherpaPak Liver Transport System approved by the FDA?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System received FDA 510(k) clearance on 2020-01-16, under approval number K192869.

What company makes SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is manufactured by Pragonix Technologies.

What is the FDA product code for SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

The FDA product code for SherpaPak Lung Preservation System , SherpaPak Liver Transport System is KDN.

Related Clinical Trials

NCT07578441 VitaSmart HOPE System: Bridge to HOPE Registry ENROLLING_BY_INVITATION NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02234128 Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility COMPLETED NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT07595627 Hypothermic Machine Perfusion for Liver Graft Preservation NOT_YET_RECRUITING NCT06486454 Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) RECRUITING

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. K201048SherpaPak Pediatric Liver Transport SystemParagonix 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.

↑