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FDA 510(k)

Paragonix SherpaPak Pancreas Transport System

K-Number: K191440 · 2019-12-20

ApplicantParagonix Technologies
Decision Date2019-12-20
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Paragonix SherpaPak Pancreas 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 2019-12-20 under 510(k) number K191440. 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 Paragonix SherpaPak Pancreas Transport System?

Paragonix SherpaPak Pancreas Transport System is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Paragonix Technologies. The 510(k) number is K191440.

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

Paragonix SherpaPak Pancreas Transport System received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191440.

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

The FDA product code for Paragonix SherpaPak Pancreas Transport System is KDN.

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 SystemK182735Paragonix SherpaPak Cardiac Transport SystemK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

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Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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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