Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Coroventis Research AB. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Coroventis Research AB. The 510(k) number is K252238.

When did CoroFlow Cardiovascular System receive FDA 510(k) clearance?

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

Who is the listed applicant for CoroFlow Cardiovascular System?

The FDA 510(k) record lists Coroventis Research AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoroFlow Cardiovascular System?

The FDA product code for CoroFlow Cardiovascular System is DQK.

Other records listing Coroventis Research AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201881CoroFlow Cardiovascular System

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.

↑