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510(k) K222535

OCS Lung Donor Flush Set by TransMedics, Inc. — Product Code MSB

K222535 is an FDA 510(k) premarket notification submitted by TransMedics, Inc. for the device "OCS Lung Donor Flush Set". The FDA issued a decision of Substantially Equivalent on November 18, 2022. 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. TransMedics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2022
Date Received
August 22, 2022
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 TransMedics, Inc.

  • K231362 — OCS Heart Leukocyte Depleting Filter (October 31, 2023)
  • K211314 — OCS Lung Solution (July 29, 2021)

Other clearances for product code MSB

  • 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)
  • K032794 — CUSTODIOL (April 5, 2004)
  • K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION (October 27, 2003)

FDA data resources