Clearance Summary
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 received FDA 510(k) clearance under submission number K974475, sponsored by Biocontrol Technology, Inc.. 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 1998-03-02.
- Submission: K974475
- Applicant / Sponsor: Biocontrol Technology, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1998-03-02
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.