Clearance Summary
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM received FDA 510(k) clearance under submission number K953529, 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 1996-01-26.
- Submission: K953529
- Applicant / Sponsor: Strato/Infusaid, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1996-01-26
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.