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FDA PRODUCT CODE · CLASS III

PHO — Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Preservation of donor lungs for transplantation.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
GU
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P250025Traferox Technologies, Inc. · pma2026-07-15
P240033Lung Bioengineering, Inc. · pma2026-06-22
P180014Xvivo Perfusion, Inc. · pma2025-11-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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