Clearance Summary
EPISTAXIS CATHETER/KIT received FDA 510(k) clearance under submission number K821584, sponsored by Bivona Medical Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1982-06-14.
- Submission: K821584
- Applicant / Sponsor: Bivona Medical Technologies
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4100
- Decision date: 1982-06-14
Classification & Regulation
This clearance is catalogued under FDA product code EMX and 21 CFR 874.4100, within the Ear, Nose, Throat review panel as a Class I device.