K-number	K241025
Device name	JADE PLUS PTA Balloon Dilatation Catheter
Applicant	OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code	LIT
Device class	Class II
Decision date	Jun 11, 2024
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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JADE PLUS PTA Balloon Dilatation Catheter

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