Name: Predicase
Price: 199 USD

K-number	K172455
Device name	CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
Applicant	Volcano Corporation
Product code	IYO
Device class	Class II
Decision date	Oct 25, 2017
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit

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