K-number	K191512
Device name	LotusCatheter (Lotus No Balloon Catheter)
Applicant	Hakki Medical Technologies, Inc.
Product code	GBM
Device class	Class II
Decision date	May 21, 2020
Decision	Unknown
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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LotusCatheter (Lotus No Balloon Catheter)

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