Clearance Summary
ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM received FDA 510(k) clearance under submission number K920434, sponsored by Squires & Assoc., 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 1992-04-13.
- Submission: K920434
- Applicant / Sponsor: Squires & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1992-04-13
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.