Clearance Summary
TAKA ANEURYSM CLIP received FDA 510(k) clearance under submission number K972750, sponsored by V. Mueller Neuro/Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1998-07-09.
- Submission: K972750
- Applicant / Sponsor: V. Mueller Neuro/Spine
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5200
- Decision date: 1998-07-09
Classification & Regulation
This clearance is catalogued under FDA product code HCH and 21 CFR 882.5200, within the Neurology review panel as a Class II device.