Clearance Summary
Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing received FDA 510(k) clearance under submission number K243418, sponsored by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-12-02.
- Submission: K243418
- Applicant / Sponsor: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2024-12-02
Classification & Regulation
This clearance is catalogued under FDA product code JCX and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.