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510(k) K121618

BEL-GEN COLD STORAGE SOLUTION by Waters Medical Systems, LLC — Product Code KDL

K121618 is an FDA 510(k) premarket notification submitted by Waters Medical Systems, LLC for the device "BEL-GEN COLD STORAGE SOLUTION". The FDA issued a decision of Substantially Equivalent on June 14, 2013. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880. Waters Medical Systems, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2013
Date Received
June 1, 2012
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 Waters Medical Systems, LLC

  • K121736 — PERF-GEN PULSATILE PERFUSION SOLUTION (August 16, 2013)
  • K111521 — WAVES (February 16, 2012)

Other clearances for product code KDL

  • K241239 — OrganProtex HTK Solution (January 24, 2025)
  • K221387 — BEL-GEN Cold Storage Solution (June 14, 2022)
  • K221386 — PERF-GEN Pulsatile Perfusion Solution (June 14, 2022)
  • K211842 — Servator M SALF Solution (December 20, 2021)
  • 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)
  • 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