Name: Predicase
Price: 199 USD

K-number	K230065
Device name	VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
Applicant	Fiagon GmbH
Product code	PNZ
Device class	Class II
Decision date	May 26, 2023
Decision	Substantially Equivalent
Regulation	874.4180

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Source

View the full FDA submission: accessdata.fda.gov

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VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System

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VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System