Clearance Summary
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) received FDA 510(k) clearance under submission number K964021, sponsored by Baxter Edwards. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-03-27.
- Submission: K964021
- Applicant / Sponsor: Baxter Edwards
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 1997-03-27
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.