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510(k) K211842

Servator M SALF Solution by S.A.L.F. Spa — Product Code KDL

K211842 is an FDA 510(k) premarket notification submitted by S.A.L.F. Spa for the device "Servator M SALF Solution". The FDA issued a decision of Substantially Equivalent on December 20, 2021. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880. S.A.L.F. Spa has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2021
Date Received
June 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
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)
  • K202652 — Servator P SALF Solution with THAM (August 19, 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)

Other clearances for product code KDL

  • K241239 — OrganProtex HTK Solution (January 24, 2025)
  • K221386 — PERF-GEN Pulsatile Perfusion Solution (June 14, 2022)
  • K221387 — BEL-GEN Cold Storage Solution (June 14, 2022)
  • K192408 — Custodiol HTK Solution (April 24, 2020)
  • K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml (October 20, 2017)
  • K121736 — PERF-GEN PULSATILE PERFUSION SOLUTION (August 16, 2013)
  • K121618 — BEL-GEN COLD STORAGE SOLUTION (June 14, 2013)
  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
  • K043461 — CUSTODIOL (February 28, 2005)
  • K020924 — CUSTODIOL HTK SOLUTION (January 6, 2003)

FDA data resources