Clearance Summary
Vessel Dilator received FDA 510(k) clearance under submission number K163524, sponsored by Fetzer Medical GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-06-29.
- Submission: K163524
- Applicant / Sponsor: Fetzer Medical GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4475
- Decision date: 2017-06-29
Classification & Regulation
This clearance is catalogued under FDA product code DWP and 21 CFR 870.4475, within the Cardiovascular review panel as a Class II device.