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510(k) K032794

CUSTODIOL by Dr. Franz Kohler Chemie GmbH — Product Code MSB

K032794 is an FDA 510(k) premarket notification submitted by Dr. Franz Kohler Chemie GmbH for the device "CUSTODIOL". The FDA issued a decision of Substantially Equivalent on April 5, 2004. 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. Dr. Franz Kohler Chemie GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2004
Date Received
September 8, 2003
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 Dr. Franz Kohler Chemie GmbH

  • K192408 — Custodiol HTK Solution (April 24, 2020)
  • K043461 — CUSTODIOL (February 28, 2005)
  • K020924 — CUSTODIOL HTK SOLUTION (January 6, 2003)
  • K992209 — CUSTODIOL (December 10, 1999)

Other clearances for product code MSB

  • K222535 — OCS Lung Donor Flush Set (November 18, 2022)
  • K211314 — OCS Lung Solution (July 29, 2021)
  • K190063 — Servator C SALF Solution (August 14, 2019)
  • 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)
  • K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION (October 27, 2003)

FDA data resources