Clearance Summary
MULTILUMEN INTRAVENOUS INFUSION CATHETER received FDA 510(k) clearance under submission number K821220, sponsored by Clincal Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1982-07-09.
- Submission: K821220
- Applicant / Sponsor: Clincal Instruments Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1982-07-09
Classification & Regulation
This clearance is catalogued under FDA product code GBP and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.