Clearance Summary
DESERET ARTERIAL CATHETER received FDA 510(k) clearance under submission number K851327, 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 1985-06-14.
- Submission: K851327
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1985-06-14
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.