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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pancreatic Stent, Covered, Metallic, Removable
510(k) Number K181905
Device Name AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Kayla Mackey
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Kayla Mackey
Regulation Number876.5015
Classification Product Code
PCU  
Subsequent Product Code
KNS  
Date Received07/16/2018
Decision Date 03/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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