K-number	K231954
Device name	Aristotle 18 Guidewire; Aristotle 24 Guidewire
Applicant	Scientia Vascular, Inc.
Product code	MOF
Device class	Class II
Decision date	Aug 1, 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 18 Guidewire; Aristotle 24 Guidewire

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