Clearance Summary
ULTRAGUIDE CTG 2000SA received FDA 510(k) clearance under submission number K022354, sponsored by Ultraguide , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-08-13.
- Submission: K022354
- Applicant / Sponsor: Ultraguide , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2002-08-13
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.