K-number	K142954
Device name	PTA 14 Balloon Dilatation Catheter OTW
Applicant	Texasmedical Technologies, Inc.
Product code	LIT
Device class	Class II
Decision date	May 28, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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PTA 14 Balloon Dilatation Catheter OTW

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