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FDA 510(k)

X°Port Heart Preservation System

K-Number: K261913 · 2026-09-16

ApplicantTraferox Technologies, Inc.
Decision Date2026-09-16
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

X°Port Heart Preservation System is the device name listed in this FDA 510(k) record. The listed applicant is Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261913. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X°Port Heart Preservation System?

X°Port Heart Preservation System is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K261913.

When did X°Port Heart Preservation System receive FDA 510(k) clearance?

X°Port Heart Preservation System received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261913.

Who is the listed applicant for X°Port Heart Preservation System?

The FDA 510(k) record lists Traferox Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X°Port Heart Preservation System?

The FDA product code for X°Port Heart Preservation System is MSB.

Related Clinical Trials

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.

NCT0781894110 Degree C Static Storage in Heart TransplantationNOT_YET_RECRUITING

Other records listing Traferox Technologies, Inc. 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.

PMA P250025Normothermic preservation system for transplantation of initially unacceptable donor lungsK260456VI°Port™ Liver Preservation SystemK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionK240650LungProtect

Related Devices (Code: MSB)

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.

K222535OCS Lung Donor Flush SetTransMedics, Inc.K211314OCS Lung SolutionTransMedics, Inc.K190063Servator C SALF SolutionS.A.L.F. SpaK182735Paragonix SherpaPak Cardiac Transport SystemParagonix TechnologiesK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc.

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.

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