Name: Predicase
Price: 199 USD

K-number	K172386
Device name	1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
Applicant	Volcano Atheromed, Inc.
Product code	MCW
Device class	Class II
Decision date	Aug 24, 2017
Decision	Substantially Equivalent
Regulation	870.4875

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

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