Clearance Summary
Riptide Aspiration System (React 71 Catheter) received FDA 510(k) clearance under submission number K182101, sponsored by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-11-14.
- Submission: K182101
- Applicant / Sponsor: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2018-11-14
Classification & Regulation
This clearance is catalogued under FDA product code NRY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.