Axium Detachable Coil; Axium Prime Detachable Coil
FDA 510(k) clearance K233420 · decided 2023-11-07
Clearance details
- K-number
- K233420
- Device name
- Axium Detachable Coil; Axium Prime Detachable Coil
- Applicant
- Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
- Decision
- Substantially Equivalent
- Date received
- 2023-10-10
- Decision date
- 2023-11-07
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.