AXIOS Stent And Electrocautery-Enhanced Delivery System

Pancreatic Stent, Covered, Metallic, Removable

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Axios Stent And Electrocautery-enhanced Delivery System.

Pre-market Notification Details

Device IDK220112
510k NumberK220112
Device Name:AXIOS Stent And Electrocautery-Enhanced Delivery System
ClassificationPancreatic Stent, Covered, Metallic, Removable
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactIan Broome
CorrespondentIan Broome
Boston Scientific Corporation 200 Boston Scientific Way, Mail Stop M41 Marlborough,  MA  01752
Product CodePCU  
CFR Regulation Number876.5015 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-13
Decision Date2022-09-07

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