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FDA 510(k) Application Details - K203132
Device Classification Name
More FDA Info for this Device
510(K) Number
K203132
Device Name
AXIOS Stent and Electrocautery Enhanced Delivery System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
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Contact
Aparna Philip
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Regulation Number
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Classification Product Code
PCU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/19/2020
Decision Date
04/15/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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