AXIOS STENT AND DELIVERY SYSTEM
FDA 510(k) clearance DEN130007 · decided 2013-12-18
Clearance details
- K-number
- DEN130007
- Device name
- AXIOS STENT AND DELIVERY SYSTEM
- Applicant
- Xlumena, Inc.
- Decision
- Unknown
- Date received
- 2013-02-19
- Decision date
- 2013-12-18
- Days to decision
- 302 days
- Clearance type
- Post-NSE
- 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.