Clearance Summary
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA received FDA 510(k) clearance under submission number K002723, 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 2000-09-28.
- Submission: K002723
- Applicant / Sponsor: Micro Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2000-09-28
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.