BAROguard Donor Lung Preservation System— 510(k) K254305

Substantially Equivalent

Paragonix Technologies, Inc.

FDA 510(k) clearance K254305 for BAROguard Donor Lung Preservation System, Substantially Equivalent on 2026-01-30. Applicant: Paragonix Technologies, Inc..

Clearance details

Applicant: Paragonix Technologies, Inc.
Product code: Code KDN
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-31
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

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