Clearance Summary
Geomed Vascular Dilators received FDA 510(k) clearance under submission number K183438, sponsored by Geomed Medizin-Technik GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-09-03.
- Submission: K183438
- Applicant / Sponsor: Geomed Medizin-Technik GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4475
- Decision date: 2019-09-03
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.