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FDA 510(k)

OrganProtex HTK Solution

K-Number: K241239 · 2025-01-24

ApplicantBridge TO Life, Ltd.
Decision Date2025-01-24
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OrganProtex HTK Solution is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) 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. The listed applicant is Bridge TO Life, Ltd.. The 510(k) number is K241239.

When did OrganProtex HTK Solution receive FDA 510(k) clearance?

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

Who is the listed applicant for OrganProtex HTK Solution?

The FDA 510(k) record lists Bridge TO Life, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrganProtex HTK Solution?

The FDA product code for OrganProtex HTK Solution is KDL.

Related Clinical Trials

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NCT05045794Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver TransplantationCOMPLETEDNCT07578441VitaSmart HOPE System: Bridge to HOPE RegistryENROLLING_BY_INVITATION

Other records listing Bridge TO Life, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)K243384Belzer UW® Cold Storage Solution (BTLBUW-001)K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)K203262Cannula for Organ PerfusionK191006EasiSlush

Related Devices (Code: KDL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221387BEL-GEN Cold Storage SolutionInstitut Georges LopezK221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges LopezK211842Servator M SALF SolutionS.A.L.F. SpaK192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbHK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

Official Source

View on FDA Database →

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

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