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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 a medical device manufactured by Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2021-07-01 under approval 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. It is manufactured by Bridge TO Life, Ltd.. The 510(k) number is K203262.

When was Cannula for Organ Perfusion approved by the FDA?

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

What company makes Cannula for Organ Perfusion?

Cannula for Organ Perfusion is manufactured by Bridge TO Life, Ltd..

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

NCT05574361 Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) ACTIVE_NOT_RECRUITING NCT06874296 Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time RECRUITING NCT07515716 Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia NOT_YET_RECRUITING

Other Devices by Bridge TO Life, Ltd.

K191006EasiSlush K241239OrganProtex HTK Solution DEN250009VitaSmart Hypothermic Oxygenated Perfusion System

Related Devices (Code: KDN)

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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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