Clearance Summary
PERFADEX AND PERFADEX WITH THAM received FDA 510(k) clearance under submission number K091989, sponsored by Xvivo Perfusion AB. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-10-01.
- Submission: K091989
- Applicant / Sponsor: Xvivo Perfusion AB
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 2010-10-01
Classification & Regulation
This clearance is catalogued under FDA product code KDN and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.