Clearance Summary
STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM received FDA 510(k) clearance under submission number K953436, 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 1995-10-04.
- Submission: K953436
- Applicant / Sponsor: Strato/Infusaid, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 1995-10-04
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.