Clearance Summary
I.V. FILTER SET received FDA 510(k) clearance under submission number K933523, sponsored by Mediziv Medical Products 1987 , Ltd.. 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 1995-05-19.
- Submission: K933523
- Applicant / Sponsor: Mediziv Medical Products 1987 , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1995-05-19
Classification & Regulation
This clearance is catalogued under FDA product code FPB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.