FDA 510(k)

OrganProtex HTK Solution

K-Number: K241239 · 2025-01-24

Decision Date2025-01-24

Product CodeKDL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OrganProtex HTK Solution is a medical device manufactured by Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2025-01-24 under approval number K241239. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrganProtex HTK Solution?

OrganProtex HTK Solution is a medical device that received FDA 510(k) clearance on 2025-01-24. It is manufactured by Bridge TO Life, Ltd.. The 510(k) number is K241239.

When was OrganProtex HTK Solution approved by the FDA?

OrganProtex HTK Solution received FDA 510(k) clearance on 2025-01-24, under approval number K241239.

What company makes OrganProtex HTK Solution?

OrganProtex HTK Solution is manufactured by Bridge TO Life, Ltd..

What is the FDA product code for OrganProtex HTK Solution?

The FDA product code for OrganProtex HTK Solution is KDL.

Other Devices by Bridge TO Life, Ltd.

K191006EasiSlush K203262Cannula for Organ Perfusion DEN250009VitaSmart Hypothermic Oxygenated Perfusion System

Related Devices (Code: KDL)

K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa K192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH K211842Servator M SALF SolutionS.A.L.F. Spa K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez K221387BEL-GEN Cold Storage SolutionInstitut Georges Lopez

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.