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FDA 510(k), K140561, AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
FDA 510(k), K140561, AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
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510(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)
Manufacturer: XLUMENA, INC.
Device Classification Name: pancreatic stent, covered, metallic, removable
Regulation Number: 876.5015
Classification Product Code: PCU
Date Received: 03/05/2014
Decision Date: 04/23/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
Manufacturer: XLUMENA, INC.
Device Classification Name: pancreatic stent, covered, metallic, removable
Regulation Number: 876.5015
Classification Product Code: PCU
Date Received: 03/05/2014
Decision Date: 04/23/2014
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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