Perfadex Plus— 510(k) K261644
Substantially EquivalentXvivo Perfusion AB
FDA 510(k) clearance K261644 for Perfadex Plus, Substantially Equivalent on 2026-07-23. Applicant: Xvivo Perfusion AB. Device class: 2.
Summary
Xvivo Perfusion's Perfadex Plus is filed under KDN, kidney perfusion systems. The record doesn't describe the product's form or composition.
Class II, 21 CFR 876.5880. Gastroenterology and Urology is both the classification panel and the review panel, and it was a Traditional 510(k).
Xvivo filed from Mölndal, Sweden. Review took 66 calendar days (May 18 to July 23, 2026).
Clearance details
- Applicant
- Xvivo Perfusion AB
- Product code
- Product code KDN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mölndal, SE
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