Name: Predicase
Price: 199 USD

K-number	K211044
Device name	Sublime Radial Access 018 RX Dilatation Catheter
Applicant	Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
Product code	LIT
Device class	Class II
Decision date	Jun 16, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Sublime Radial Access 018 RX Dilatation Catheter

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