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FDA 510(k)

Cannula for Organ Perfusion

K-Number: K203262 · 2021-07-01

ApplicantBridge TO Life, Ltd.
Decision Date2021-07-01
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cannula for Organ Perfusion 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 2021-07-01 under 510(k) number K203262. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cannula for Organ Perfusion?

Cannula for Organ Perfusion is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Bridge TO Life, Ltd.. The 510(k) number is K203262.

When did Cannula for Organ Perfusion receive FDA 510(k) clearance?

Cannula for Organ Perfusion received FDA 510(k) clearance on 2021-07-01, under 510(k) number K203262.

Who is the listed applicant for Cannula for Organ Perfusion?

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 Cannula for Organ Perfusion?

The FDA product code for Cannula for Organ Perfusion is KDN.

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.

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)K241239OrganProtex HTK SolutionK191006EasiSlush

Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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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