K-number	K193279
Device name	Comet II Pressure Guidewire
Applicant	Boston Scientific Corporation
Product code	DXO
Device class	Class II
Decision date	Dec 23, 2019
Decision	Substantially Equivalent
Regulation	870.2870

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Source

View the full FDA submission: accessdata.fda.gov

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Comet II Pressure Guidewire

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