510(k) K211333
K211333 is an FDA 510(k) premarket notification submitted by Xvivo Perfusion AB for the device "KIDNEY ASSIST-transport". The FDA issued a decision of Substantially Equivalent on January 20, 2022. 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
- January 20, 2022
- Date Received
- May 3, 2021
- 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