Clearance Summary
ABLE CENTRAL VENOUS CATHETER received FDA 510(k) clearance under submission number K070451, sponsored by Foshan Nanhai Bai HE Medical Technology Co., 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 2007-07-31.
- Submission: K070451
- Applicant / Sponsor: Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2007-07-31
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.