K-number	K254305
Device name	BAROguard Donor Lung Preservation System
Applicant	Paragonix Technologies, Inc.
Product code	KDN
Device class	Class II
Decision date	Jan 30, 2026
Decision	Substantially Equivalent
Regulation	876.5880

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Source

View the full FDA submission: accessdata.fda.gov

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BAROguard Donor Lung Preservation System

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