Clearance Summary
DESERET INFANT CENTRAL VENOUS CATHE- received FDA 510(k) clearance under submission number K840116, sponsored by Parke-Davis Co.. 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 1984-03-22.
- Submission: K840116
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1984-03-22
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.