Clearance Summary
Medcomp Vessel Dilator received FDA 510(k) clearance under submission number K162389, sponsored by Medcomp ( Medical Components). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-06-01.
- Submission: K162389
- Applicant / Sponsor: Medcomp ( Medical Components)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2017-06-01
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.