Clearance Summary
MTI 1 ML SYRINGE received FDA 510(k) clearance under submission number K991225, sponsored by Micro Therapeutics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-07-08.
- Submission: K991225
- Applicant / Sponsor: Micro Therapeutics, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1999-07-08
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.