Name: Predicase
Price: 199 USD

K-number	K252238
Device name	CoroFlow Cardiovascular System
Applicant	Coroventis Research AB
Product code	DQK
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	870.1425

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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CoroFlow Cardiovascular System

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