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510(k) K252238

CoroFlow Cardiovascular System by Coroventis Research AB — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
July 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Coroventis Research AB

  • K201881 — CoroFlow Cardiovascular System (November 13, 2020)

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