K-number	K153688
Device name	Edi Catheter ENFit
Applicant	Maquet Critical Care AB
Product code	PIF
Device class	Class II
Decision date	Mar 2, 2017
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Edi Catheter ENFit

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