K233420
- 510(k) number
- K233420
- Device name
- Axium Detachable Coil; Axium Prime Detachable Coil
- Applicant
- Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular CA · US
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2023-11-07
- Date received
- 2023-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K233420.pdf
Official FDA record: K233420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.