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510(k) K190063

Servator C SALF Solution by S.A.L.F. Spa — Product Code MSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2019
Date Received
January 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System And Accessories, Isolated Heart, Transport And Preservation
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)
  • K202652 — Servator P SALF Solution with THAM (August 19, 2021)
  • 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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  • K180194 — SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (March 30, 2018)
  • K143074 — Sherpa Pak Cardiac Transport System (November 25, 2014)
  • K133432 — SHERPA PAK CARDIAC TRANSPORT SYSTEM (February 21, 2014)
  • K123326 — SHERPA PAK CARDIAC TRANSPORT SYSTEM (February 6, 2013)
  • K081997 — PERFADEX WITH THAM (October 9, 2008)
  • K032794 — CUSTODIOL (April 5, 2004)
  • K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION (October 27, 2003)