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510(k) K153088

AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System by Boston Scientific Corporation — Product Code PCU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2015
Date Received
October 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pancreatic Stent, Covered, Metallic, Removable
Device Class
Class II
Regulation Number
876.5015
Review Panel
GU
Submission Type

To facilitate transmural endoscopic drainage of pancreatic pseudocysts

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