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FDA 510(k), K153088, AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
FDA 510(k), K153088, AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
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510(K) Number: K153088
Device Name: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Device Classification Name: pancreatic stent, covered, metallic, removable
Regulation Number: 876.5015
Classification Product Code: PCU
Date Received: 10/26/2015
Decision Date: 12/11/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Device Classification Name: pancreatic stent, covered, metallic, removable
Regulation Number: 876.5015
Classification Product Code: PCU
Date Received: 10/26/2015
Decision Date: 12/11/2015
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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