Clearance Summary
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI received FDA 510(k) clearance under submission number K993257, sponsored by Micro Therapeutics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-10-21.
- Submission: K993257
- Applicant / Sponsor: Micro Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1999-10-21
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.