K-number	K981191
Device name	ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
Applicant	Intratherapeutics, Inc.
Product code	DQY
Device class	Class II
Decision date	Apr 7, 1999
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65

Everything you need for a 510(k) submission. Nothing you don't.