K-number	K203358
Device name	Solitaire X Revascularization Device
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code	POL
Device class	Class II
Decision date	Mar 1, 2021
Decision	Substantially Equivalent
Regulation	882.5600

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Source

View the full FDA submission: accessdata.fda.gov

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Solitaire X Revascularization Device

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