Clearance Summary
SNAP-LOCK MICRO PORT, MODIFICATION received FDA 510(k) clearance under submission number K910448, sponsored by Infusaid 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 1991-11-21.
- Submission: K910448
- Applicant / Sponsor: Infusaid Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1991-11-21
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.