Home / 510(k) Clearances / K190063

510(k) K190063

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

K190063 is an FDA 510(k) premarket notification submitted by S.A.L.F. Spa for the device "Servator C SALF Solution". The FDA issued a decision of Substantially Equivalent on August 14, 2019. The device falls under product code MSB (System And Accessories, Isolated Heart, Transport And Preservation), 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
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)

Other clearances for product code MSB

  • K222535 — OCS Lung Donor Flush Set (November 18, 2022)
  • K211314 — OCS Lung Solution (July 29, 2021)
  • K182735 — Paragonix SherpaPak Cardiac Transport System (October 19, 2018)
  • 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)

FDA data resources