K-number	K222663
Device name	MultiStage Balloon Dilatation Catheter
Applicant	Dongguan TT Medical, Inc.
Product code	FGE
Device class	Class II
Decision date	Mar 9, 2023
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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MultiStage Balloon Dilatation Catheter

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