Name: Predicase
Price: 199 USD

K-number	K183636
Device name	SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Applicant	Boston Scientific Corporation
Product code	FBN
Device class	Class II
Decision date	Jan 22, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

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