Name: Predicase
Price: 199 USD

K-number	K181905
Device name	AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
Applicant	Boston Scientific Corporation
Product code	PCU
Device class	Class II
Decision date	Mar 25, 2019
Decision	Substantially Equivalent
Regulation	876.5015

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Source

View the full FDA submission: accessdata.fda.gov

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AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

Everything you need for a 510(k) submission. Nothing you don't.