FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
CoroFlow Cardiovascular System
K Number: K252238
·
Decision Oct 24, 2025
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
2
Review Days
99
Basic Information
- Device Name
- CoroFlow Cardiovascular System
- K Number
- K252238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coroventis Research AB
- Date Received
- July 17, 2025
- Decision Date
- October 24, 2025
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
| K201881 | CoroFlow Cardiovascular System | Nov 13, 2020 | Substantially Equivalent |