FDA 510(k)

Belzer UW® Cold Storage Solution (BTLBUW-001)

K-Number: K243384 · 2025-03-31

Decision Date2025-03-31

Product CodeKDN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Belzer UW® Cold Storage Solution (BTLBUW-001) is a medical device manufactured by Bridge TO Life. It received FDA 510(k) clearance on 2025-03-31 under approval number K243384. 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 Belzer UW® Cold Storage Solution (BTLBUW-001)?

Belzer UW® Cold Storage Solution (BTLBUW-001) is a medical device that received FDA 510(k) clearance on 2025-03-31. It is manufactured by Bridge TO Life. The 510(k) number is K243384.

When was Belzer UW® Cold Storage Solution (BTLBUW-001) approved by the FDA?

Belzer UW® Cold Storage Solution (BTLBUW-001) received FDA 510(k) clearance on 2025-03-31, under approval number K243384.

What company makes Belzer UW® Cold Storage Solution (BTLBUW-001)?

Belzer UW® Cold Storage Solution (BTLBUW-001) is manufactured by Bridge TO Life.

What is the FDA product code for Belzer UW® Cold Storage Solution (BTLBUW-001)?

The FDA product code for Belzer UW® Cold Storage Solution (BTLBUW-001) is KDN.

Other Devices by Bridge TO Life

K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Related Devices (Code: KDN)

K153384Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation K180481Servator B SALF SolutionS.A.L.F. Spa K170826Perfadex PlusXvivo Perfusion AB K191440Paragonix SherpaPak Pancreas Transport SystemParagonix Technologies K191006EasiSlushBridge TO Life, Ltd. K201048SherpaPak Pediatric Liver Transport SystemParagonix Technologies

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.