K-number	K843944
Device name	PTCA BALLOON CATHETERS & ACCESSORIES
Applicant	Advanced Cardiovascular Systems, Inc.
Product code	LOX
Device class	Class II
Decision date	Feb 14, 1985
Decision	Substantially Equivalent
Regulation	870.5100

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View the full FDA submission: accessdata.fda.gov

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PTCA BALLOON CATHETERS & ACCESSORIES

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