Clearance Summary
VASC-ALERT received FDA 510(k) clearance under submission number K042566, sponsored by Vasc-Alert, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-11-08.
- Submission: K042566
- Applicant / Sponsor: Vasc-Alert, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2004-11-08
Classification & Regulation
This clearance is catalogued under FDA product code MQS and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.