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510(k) K152572

AXIOS Stent and Delivery System by Boston Scientific Corporation — Product Code PCU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2015
Date Received
September 9, 2015
Clearance Type
Special
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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  • K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System (August 26, 2019)
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