Paragonix Technologies Inc., Announces Filing Of A 510(K) Pre-Market Notification With FDA For The Paragonix Sherpa Perfusion™ Cardiac Transport System

BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that it has successfully completed filing of a 510(k) Pre-market notification with the US Food and Drug Administration (FDA) for its Sherpa Perfusion™ Cardiac Transport System (CTS)1,2. This represents the fourth pre-market application for the Company’s Sherpa family of organ preservation and transport technologies. The Sherpa Perfusion™ CTS is intended to be used for either hypothermic static preservation or oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Sherpa Perfusion Cardiac Transport System is up to 4 hours.

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