Clearance Summary
Phenom Catheters received FDA 510(k) clearance under submission number K210230, sponsored by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-02-25.
- Submission: K210230
- Applicant / Sponsor: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2021-02-25
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.