Name: Predicase
Price: 199 USD

K-number	K242419
Device name	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Applicant	Creagh Medical Ltd. Dba Surmodics, Inc.
Product code	LIT
Device class	Class II
Decision date	Nov 15, 2024
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

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