K-number	K233433
Device name	Sphere-9Dx Diagnostic Catheter (AFR-00009)
Applicant	Medtronic
Product code	MTD
Device class	Class II
Decision date	Aug 7, 2024
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Sphere-9Dx Diagnostic Catheter (AFR-00009)

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