Name: Predicase
Price: 199 USD

K-number	K163314
Device name	Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
Applicant	Boston Scientific Corporation
Product code	DQY
Device class	Class II
Decision date	Mar 23, 2017
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

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