Name: Predicase
Price: 199 USD

K-number	K190753
Device name	EverCrossTM 0.035 OTW PTA Dilatation Catheter
Applicant	Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
Product code	LIT
Device class	Class II
Decision date	Apr 23, 2019
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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EverCrossTM 0.035 OTW PTA Dilatation Catheter

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