Clearance Summary
MICROFLO-SAFE SCALP VEIN SET received FDA 510(k) clearance under submission number K043328, sponsored by Dks Loversan Industria Biomedica Spa. 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 2005-04-15.
- Submission: K043328
- Applicant / Sponsor: Dks Loversan Industria Biomedica Spa
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2005-04-15
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.