Clearance Summary
VENUSA, LTD. EXTENSION SET WITH FILTER received FDA 510(k) clearance under submission number K994429, sponsored by Venusa , 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 2000-03-03.
- Submission: K994429
- Applicant / Sponsor: Venusa , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2000-03-03
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.