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510(k) K192408

Custodiol HTK Solution by Dr. Franz Kohler Chemie GmbH — Product Code KDL

K192408 is an FDA 510(k) premarket notification submitted by Dr. Franz Kohler Chemie GmbH for the device "Custodiol HTK Solution". The FDA issued a decision of Substantially Equivalent on April 24, 2020. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880. Dr. Franz Kohler Chemie GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2020
Date Received
September 4, 2019
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 Dr. Franz Kohler Chemie GmbH

  • K043461 — CUSTODIOL (February 28, 2005)
  • K032794 — CUSTODIOL (April 5, 2004)
  • K020924 — CUSTODIOL HTK SOLUTION (January 6, 2003)
  • K992209 — CUSTODIOL (December 10, 1999)

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)
  • 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