Clearance Summary
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 received FDA 510(k) clearance under submission number K100334, sponsored by B. Braun Avitum AG. 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 2010-04-22.
- Submission: K100334
- Applicant / Sponsor: B. Braun Avitum AG
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2010-04-22
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.