The following data is part of a premarket notification filed by Coroventis Research Ab with the FDA for Coroflow Cardiovascular System.
| Device ID | K201881 |
| 510k Number | K201881 |
| Device Name: | CoroFlow Cardiovascular System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Coroventis Research AB Ulls Vag 29A Uppsala, SE 75651 |
| Contact | Johan Svanerud |
| Correspondent | Johan Svanerud Coroventis Research AB Ulls Vag 29A Uppsala, SE 75651 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2020-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350111070014 | K201881 | 000 |
| 07350111070663 | K201881 | 000 |