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510(k) K202652

Servator P SALF Solution with THAM by S.A.L.F. Spa — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2021
Date Received
September 14, 2020
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 S.A.L.F. Spa

  • K230193 — Servator P Plus SALF Solution (September 21, 2023)
  • K211842 — Servator M SALF Solution (December 20, 2021)
  • K190063 — Servator C SALF Solution (August 14, 2019)
  • K180481 — Servator B SALF Solution (June 29, 2018)
  • K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml (October 20, 2017)

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  • K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution (May 1, 2025)
  • K243998 — DCX Disposable Cassette (DCX) (April 25, 2025)
  • K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) (March 31, 2025)
  • K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (March 26, 2025)
  • K240650 — LungProtect (November 26, 2024)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K230193 — Servator P Plus SALF Solution (September 21, 2023)
  • K223874 — BAROguard (August 15, 2023)