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FDA 510(k)

Paragonix SherpaPak Cardiac Transport System

K-Number: K182735 · 2018-10-19

ApplicantParagonix Technologies
Decision Date2018-10-19
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Paragonix SherpaPak Cardiac Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K182735. 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 Paragonix SherpaPak Cardiac Transport System?

Paragonix SherpaPak Cardiac Transport System is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Paragonix Technologies. The 510(k) number is K182735.

When did Paragonix SherpaPak Cardiac Transport System receive FDA 510(k) clearance?

Paragonix SherpaPak Cardiac Transport System received FDA 510(k) clearance on 2018-10-19, under 510(k) number K182735.

Who is the listed applicant for Paragonix SherpaPak Cardiac Transport System?

The FDA 510(k) record lists Paragonix Technologies as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Paragonix Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254305BAROguard Donor Lung Preservation SystemK234060KIDNEYvault Portable Renal Perfusion SystemK223874BAROguardK201048SherpaPak Pediatric Liver Transport SystemK191440Paragonix SherpaPak Pancreas Transport SystemK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

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Related Devices (Code: MSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222535OCS Lung Donor Flush SetTransMedics, Inc.K211314OCS Lung SolutionTransMedics, Inc.K190063Servator C SALF SolutionS.A.L.F. SpaK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, 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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