KIDNEY ASSIST-transport— 510(k) K211333

Substantially Equivalent

Xvivo Perfusion AB

FDA 510(k) clearance K211333 for KIDNEY ASSIST-transport, Substantially Equivalent on 2022-01-20. Applicant: Xvivo Perfusion AB. Device class: 2.

Clearance details

Applicant: Xvivo Perfusion AB
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2021-05-03
Decision date: 2022-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

Download summary PDF View on FDA.gov ↗

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More clearances from Xvivo Perfusion AB

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Data sourced from openFDA. This site is unofficial and independent of the FDA.