K-number	K142983
Device name	AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Applicant	Angioscore, Inc.
Product code	PNO
Device class	Class II
Decision date	Mar 4, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating

Everything you need for a 510(k) submission. Nothing you don't.