Clearance Summary
Concerto Versa, Detachable Coil received FDA 510(k) clearance under submission number K202850, 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 2021-02-09.
- Submission: K202850
- Applicant / Sponsor: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3300
- Decision date: 2021-02-09
Classification & Regulation
This clearance is catalogued under FDA product code KRD and 21 CFR 870.3300, within the Cardiovascular review panel as a Class II device.