K-number	K963688
Device name	FOCUS PV BALLOON DILATATION CATHETER
Applicant	Cardiovascular Dynamics, Inc.
Product code	LIT
Device class	Class II
Decision date	Mar 28, 1997
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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FOCUS PV BALLOON DILATATION CATHETER

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