Clearance Summary
INFUSAID INFUSE-A-PORT (MODIFIED) received FDA 510(k) clearance under submission number K853981, sponsored by Intermedics/Infusaid, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1985-12-18.
- Submission: K853981
- Applicant / Sponsor: Intermedics/Infusaid, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1985-12-18
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.