Clearance Summary
VenSure Balloon Device, VenSure Nav Balloon Device received FDA 510(k) clearance under submission number K201472, sponsored by Fiagon GmbH. 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 2020-08-26.
- Submission: K201472
- Applicant / Sponsor: Fiagon GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2020-08-26
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.