K-number	K143093
Device name	0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
Applicant	Hotspur Technologies, Inc.,
Product code	LIT
Device class	Class II
Decision date	Jun 24, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)

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