K-number	K233505
Device name	Sapphire ULTRA Coronary Dilatation Catheter
Applicant	OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Aug 15, 2024
Decision	Substantially Equivalent
Regulation	870.5100

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View the full FDA submission: accessdata.fda.gov

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Sapphire ULTRA Coronary Dilatation Catheter

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