Clearance Summary
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) received FDA 510(k) clearance under submission number K040694, sponsored by Micro Therapeutics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-03-25.
- Submission: K040694
- Applicant / Sponsor: Micro Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2004-03-25
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.