AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)— 510(k) K140561
Substantially EquivalentXlumena, Inc.
FDA 510(k) clearance K140561 for AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT), Substantially Equivalent on 2014-04-23. Applicant: Xlumena, Inc.. Device class: 2.
Clearance details
- Applicant
- Xlumena, Inc.
- Product code
- Code PCU
- Device class
- Class 2
- Regulation
- 21 CFR 876.5015
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
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More clearances from Xlumena, Inc.
view allAdverse events under product code PCU
product code PCU- Death
- 47
- Injury
- 804
- Malfunction
- 709
- Total
- 1,560
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.