Clearance Summary
ADVANCED DIAGNOSTIC VIEWER (ADV) received FDA 510(k) clearance under submission number K963697, sponsored by Bio-Vascular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-11-27.
- Submission: K963697
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1996-11-27
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.