K-number	K921147
Device name	CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
Applicant	Cardiovascular Imaging Systems, Inc.
Product code	ITX
Device class	Class II
Decision date	Jun 16, 1992
Decision	Substantially Equivalent
Regulation	892.1570

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View the full FDA submission: accessdata.fda.gov

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CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE

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