Name: Predicase
Price: 199 USD

K-number	K160583
Device name	REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
Applicant	Volcano Corporation
Product code	OBJ
Device class	Class II
Decision date	Oct 26, 2016
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

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