K-number	K192360
Device name	IntellaMap Orion High Resolution Mapping Catheter
Applicant	Boston Scientific Corporation
Product code	DRF
Device class	Class II
Decision date	Oct 25, 2019
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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IntellaMap Orion High Resolution Mapping Catheter

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