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FDA 510(k)

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)

K-Number: K243618 · 2025-06-17

ApplicantBridge TO Life
Decision Date2025-06-17
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life. It received FDA 510(k) clearance on 2025-06-17 under 510(k) number K243618. 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® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)?

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Bridge TO Life. The 510(k) number is K243618.

When did EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) receive FDA 510(k) clearance?

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) received FDA 510(k) clearance on 2025-06-17, under 510(k) number K243618.

Who is the listed applicant for EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)?

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

What is the FDA product code for EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)?

The FDA product code for EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) 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 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.

K243384Belzer UW® Cold Storage Solution (BTLBUW-001)K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)K241239OrganProtex HTK SolutionK203262Cannula for Organ PerfusionK191006EasiSlush

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.K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges LopezK243384Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life

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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