Perfadex Plus— 510(k) K170826

Substantially Equivalent

Xvivo Perfusion AB

FDA 510(k) clearance K170826 for Perfadex Plus, Substantially Equivalent on 2018-06-22. 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: 2017-03-20
Decision date: 2018-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sloane, SE

Download summary PDF View on FDA.gov ↗

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