Clearance Summary
THORO/CATH STRAIGHT THORACIC RIGHT ANGLE received FDA 510(k) clearance under submission number K853131, sponsored by J. H. Emerson Co.. 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 1985-09-05.
- Submission: K853131
- Applicant / Sponsor: J. H. Emerson Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1985-09-05
Classification & Regulation
This clearance is catalogued under FDA product code GBS and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.