Clearance Summary
SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM received FDA 510(k) clearance under submission number K890518, sponsored by Harbor Medical Devices, 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 1989-04-21.
- Submission: K890518
- Applicant / Sponsor: Harbor Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1989-04-21
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.