CoroFlow Cardiovascular System
FDA 510(k) K252238 · Coroventis Research AB
510(k) numberK252238
Submission
- Device name
- CoroFlow Cardiovascular System
- Applicant
- Coroventis Research AB
Uppsala, SE - Received
- July 17, 2025
- Decision date
- October 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
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| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201881 | CoroFlow Cardiovascular SystemDQK · Traditional | 11/13/2020SE |
Questions and answers
When was CoroFlow Cardiovascular System cleared by the FDA?
CoroFlow Cardiovascular System (K252238) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 99 days after the submission was received.
What is the product code of K252238?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.