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FDA 510(k)

CoroFlow Cardiovascular System

K-Number: K252238 · 2025-10-24

ApplicantCoroventis Research AB
Decision Date2025-10-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CoroFlow Cardiovascular System is a medical device manufactured by Coroventis Research AB. It received FDA 510(k) clearance on 2025-10-24 under approval number K252238. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoroFlow Cardiovascular System?

CoroFlow Cardiovascular System is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Coroventis Research AB. The 510(k) number is K252238.

When was CoroFlow Cardiovascular System approved by the FDA?

CoroFlow Cardiovascular System received FDA 510(k) clearance on 2025-10-24, under approval number K252238.

What company makes CoroFlow Cardiovascular System?

CoroFlow Cardiovascular System is manufactured by Coroventis Research AB.

What is the FDA product code for CoroFlow Cardiovascular System?

The FDA product code for CoroFlow Cardiovascular System is DQK.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT06112418 A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events RECRUITING NCT06907147 SPYRAL GEMINI Pilot Study RECRUITING NCT05820516 Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation RECRUITING

Related PubMed Literature

PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Coroventis Research AB

K201881CoroFlow Cardiovascular System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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