510(k) K261644
K261644 is an FDA 510(k) premarket notification submitted by Xvivo Perfusion AB for the device "Perfadex Plus". The FDA issued a decision of Substantially Equivalent on July 23, 2026. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Xvivo Perfusion AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2026
- Date Received
- May 18, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Perfusion, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type