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510(k) K180194

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System by Paragonix Technologies, Inc. — Product Code MSB

K180194 is an FDA 510(k) premarket notification submitted by Paragonix Technologies, Inc. for the device "SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System". The FDA issued a decision of Substantially Equivalent on March 30, 2018. 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. Paragonix Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
January 24, 2018
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 Paragonix Technologies, Inc.

  • K254305 — BAROguard Donor Lung Preservation System (January 30, 2026)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K223874 — BAROguard (August 15, 2023)
  • K201048 — SherpaPak Pediatric Liver Transport System (July 2, 2020)
  • K191440 — Paragonix SherpaPak Pancreas Transport System (December 20, 2019)
  • K182735 — Paragonix SherpaPak Cardiac Transport System (October 19, 2018)
  • K143054 — Sherpa Pak Kidney Transport System (November 25, 2014)
  • K143074 — Sherpa Pak Cardiac Transport System (November 25, 2014)
  • K133694 — SHERPA PAK TRANSPORTER (May 23, 2014)
  • K133432 — SHERPA PAK CARDIAC TRANSPORT SYSTEM (February 21, 2014)

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)
  • 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