Clearance Summary
UNICATH SP BI-PLANE (MODEL M269 & M289) received FDA 510(k) clearance under submission number K973744, sponsored by Xre Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-12-29.
- Submission: K973744
- Applicant / Sponsor: Xre Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1997-12-29
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.