Axium Prime Detachable Coil System
FDA 510(k) clearance K162704 · decided 2017-01-03
Clearance details
- K-number
- K162704
- Device name
- Axium Prime Detachable Coil System
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decision
- Substantially Equivalent
- Date received
- 2016-09-28
- Decision date
- 2017-01-03
- Days to decision
- 97 days
- Clearance type
- Traditional
- 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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Recalls involving this device
No recalls on record reference this clearance.