Clearance Summary
STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM received FDA 510(k) clearance under submission number K951875, sponsored by Strato/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 1995-05-24.
- Submission: K951875
- Applicant / Sponsor: Strato/Infusaid, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1995-05-24
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.