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510(k) K243870

X°Port Lung Preservation System; X°Port Lung Preservation Solution by Traferox Technologies, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2025
Date Received
December 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Traferox Technologies, Inc.

  • K240650 — LungProtect (November 26, 2024)

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  • K230193 — Servator P Plus SALF Solution (September 21, 2023)
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