Clearance Summary
BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD received FDA 510(k) clearance under submission number K902588, sponsored by Gambro-Hospal, 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 1991-03-07.
- Submission: K902588
- Applicant / Sponsor: Gambro-Hospal, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1991-03-07
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.