Clearance Summary
VESSEL DILATOR received FDA 510(k) clearance under submission number K905416, sponsored by The R Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-03-25.
- Submission: K905416
- Applicant / Sponsor: The R Group
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 1991-03-25
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.