Clearance Summary
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET received FDA 510(k) clearance under submission number K955497, sponsored by Cobe Renal Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1997-09-25.
- Submission: K955497
- Applicant / Sponsor: Cobe Renal Care, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 1997-09-25
Classification & Regulation
This clearance is catalogued under FDA product code KDL and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.