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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 a medical device manufactured by Paragonix Technologies. It received FDA 510(k) clearance on 2019-12-20 under approval 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. It is manufactured by Paragonix Technologies. The 510(k) number is K191440.

When was Paragonix SherpaPak Pancreas Transport System approved by the FDA?

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

What company makes Paragonix SherpaPak Pancreas Transport System?

Paragonix SherpaPak Pancreas Transport System is manufactured by Paragonix Technologies.

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

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

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Official Source

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

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