K-number	K222437
Device name	Aristotle Colossus Guidewire
Applicant	Scientia Vascular, Inc.
Product code	MOF
Device class	Class II
Decision date	Jan 26, 2023
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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Aristotle Colossus Guidewire

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