Name: Predicase
Price: 199 USD

K-number	K201377
Device name	SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
Applicant	Cordis Corporation
Product code	LIT
Device class	Class II
Decision date	Oct 9, 2020
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter

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