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FDA 510(k)

EasiSlush

K-Number: K191006 · 2019-09-24

ApplicantBridge TO Life, Ltd.
Decision Date2019-09-24
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EasiSlush 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 2019-09-24 under 510(k) number K191006. 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 EasiSlush?

EasiSlush is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Bridge TO Life, Ltd.. The 510(k) number is K191006.

When did EasiSlush receive FDA 510(k) clearance?

EasiSlush received FDA 510(k) clearance on 2019-09-24, under 510(k) number K191006.

Who is the listed applicant for EasiSlush?

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 EasiSlush?

The FDA product code for EasiSlush 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 SolutionK203262Cannula for Organ Perfusion

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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