Name: Predicase
Price: 199 USD

K-number	K221339
Device name	Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
Applicant	Contego Medical, Inc.
Product code	LIT
Device class	Class II
Decision date	Jun 9, 2022
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

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