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510(k) K182735

Paragonix SherpaPak Cardiac Transport System by Paragonix Technologies — Product Code MSB

K182735 is an FDA 510(k) premarket notification submitted by Paragonix Technologies for the device "Paragonix SherpaPak Cardiac Transport System". The FDA issued a decision of Substantially Equivalent on October 19, 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 has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2018
Date Received
September 28, 2018
Clearance Type
Special
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

  • 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)
  • K180194 — SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (March 30, 2018)
  • K143074 — Sherpa Pak Cardiac Transport System (November 25, 2014)
  • K143054 — Sherpa Pak Kidney 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)
  • 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