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FDA 510(k)

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

K-Number: K180194 · 2018-03-30

ApplicantParagonix Technologies, Inc.
Decision Date2018-03-30
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is a medical device manufactured by Paragonix Technologies, Inc.. It received FDA 510(k) clearance on 2018-03-30 under approval number K180194. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System?

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Paragonix Technologies, Inc.. The 510(k) number is K180194.

When was SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System approved by the FDA?

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System received FDA 510(k) clearance on 2018-03-30, under approval number K180194.

What company makes SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System?

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is manufactured by Paragonix Technologies, Inc..

What is the FDA product code for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System?

The FDA product code for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is MSB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

Other Devices by Paragonix Technologies, Inc.

K254305BAROguard Donor Lung Preservation System

Related Devices (Code: MSB)

K182735Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies K190063Servator C SALF SolutionS.A.L.F. Spa K211314OCS Lung SolutionTransMedics, Inc. K222535OCS Lung Donor Flush SetTransMedics, Inc.

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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