Name: Predicase
Price: 199 USD

K-number	K140291
Device name	VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
Applicant	Volcano Corporation
Product code	IYO
Device class	Class II
Decision date	Mar 7, 2014
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS

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