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510(k) K243618

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) by Bridge TO Life — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2025
Date Received
November 22, 2024
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 Bridge TO Life

  • DEN250009 — VitaSmart Hypothermic Oxygenated Perfusion System (January 15, 2026)
  • K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) (March 31, 2025)
  • K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (March 26, 2025)
  • K241239 — OrganProtex HTK Solution (January 24, 2025)
  • K203262 — Cannula for Organ Perfusion (July 1, 2021)
  • K191006 — EasiSlush (September 24, 2019)

Other clearances for product code KDN

  • K254305 — BAROguard Donor Lung Preservation System (January 30, 2026)
  • 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)
  • K211333 — KIDNEY ASSIST-transport (January 20, 2022)