Clearance Summary
ATAD ARD CATHETER received FDA 510(k) clearance under submission number K040625, sponsored by Atad Developments , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2005-01-18.
- Submission: K040625
- Applicant / Sponsor: Atad Developments , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4260
- Decision date: 2005-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HDY and 21 CFR 884.4260, within the Obstetrics/Gynecology review panel as a Class II device.