K-number	K123264
Device name	DK-PTCA BALLOON CATHETER
Applicant	Intuit Medical, LLC
Product code	LOX
Device class	Class II
Decision date	Jan 16, 2013
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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DK-PTCA BALLOON CATHETER

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