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FDA 510(k), K101314, ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
FDA 510(k), K101314, ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
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510(K) Number: K101314
Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
Manufacturer: ELENA NIEVES
Device Classification Name: Stents, Drains And Dilators For The Biliary Ducts
Regulation Number: FGE
Classification Product Code: KXA
Date Received: 05/11/2010
Decision Date: 07/23/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
Manufacturer: ELENA NIEVES
Device Classification Name: Stents, Drains And Dilators For The Biliary Ducts
Regulation Number: FGE
Classification Product Code: KXA
Date Received: 05/11/2010
Decision Date: 07/23/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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