Clearance Summary
Health Line CT Midline Catheter received FDA 510(k) clearance under submission number K200263, sponsored by Health Line International Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-03-12.
- Submission: K200263
- Applicant / Sponsor: Health Line International Corporation
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2020-03-12
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.