Clearance Summary
INTRAVASCULAR CATHETER SET received FDA 510(k) clearance under submission number K830539, sponsored by Lab-A-Cath Corp.. 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 1983-03-17.
- Submission: K830539
- Applicant / Sponsor: Lab-A-Cath Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1983-03-17
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.