AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
FDA 510(k) clearance K140561 · decided 2014-04-23
Clearance details
- K-number
- K140561
- Device name
- AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
- Applicant
- Xlumena, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-05
- Decision date
- 2014-04-23
- Days to decision
- 49 days
- Clearance type
- Special
- Product code
- PCU
- Device class
- 2
- Regulation number
- 876.5015
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.