Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KIDNEY ASSIST-transport

K-Number: K211333 · 2022-01-20

ApplicantXvivo Perfusion AB
Decision Date2022-01-20
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KIDNEY ASSIST-transport is a medical device manufactured by Xvivo Perfusion AB. It received FDA 510(k) clearance on 2022-01-20 under approval number K211333. 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 KIDNEY ASSIST-transport?

KIDNEY ASSIST-transport is a medical device that received FDA 510(k) clearance on 2022-01-20. It is manufactured by Xvivo Perfusion AB. The 510(k) number is K211333.

When was KIDNEY ASSIST-transport approved by the FDA?

KIDNEY ASSIST-transport received FDA 510(k) clearance on 2022-01-20, under approval number K211333.

What company makes KIDNEY ASSIST-transport?

KIDNEY ASSIST-transport is manufactured by Xvivo Perfusion AB.

What is the FDA product code for KIDNEY ASSIST-transport?

The FDA product code for KIDNEY ASSIST-transport is KDN.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07556588 XVIVO Heart Transplant Study in Clinical Practice RECRUITING NCT06487273 Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis RECRUITING NCT06485596 HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. ACTIVE_NOT_RECRUITING

Other Devices by Xvivo Perfusion AB

K170826Perfadex Plus

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑