Name: Predicase
Price: 199 USD

K-number	K193548
Device name	Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code	DQX
Device class	Class II
Decision date	Jan 18, 2020
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

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