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.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mölndal, SE
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