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510(k) K211333

KIDNEY ASSIST-transport by Xvivo Perfusion AB — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2022
Date Received
May 3, 2021
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 Xvivo Perfusion AB

  • K170826 — Perfadex Plus (June 22, 2018)
  • K091989 — PERFADEX AND PERFADEX WITH THAM (October 1, 2010)

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