Clearance Summary
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET received FDA 510(k) clearance under submission number K953028, sponsored by I-Flow Corp.. 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 1995-09-28.
- Submission: K953028
- Applicant / Sponsor: I-Flow Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1995-09-28
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.