K-number	K133853
Device name	VIEWFLEX XTRA ICE CATHETER
Applicant	Irvine Biomedical, Inc., A St. Jude Medical Company
Product code	OBJ
Device class	Class II
Decision date	May 19, 2014
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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