K-number	K223077
Device name	ViewFlex Xtra ICE Catheter
Applicant	Irvine Biomedical, A St. Jude Medical Company
Product code	OBJ
Device class	Class II
Decision date	Dec 7, 2022
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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ViewFlex Xtra ICE Catheter

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