The following data is part of a premarket notification filed by Keyamed Na Inc. with the FDA for Deepvessel Ffr.
| Device ID | K213657 |
| 510k Number | K213657 |
| Device Name: | DEEPVESSEL FFR |
| Classification | Coronary Vascular Physiologic Simulation Software |
| Applicant | KeyaMed NA Inc. 107 Spring Street Seattle, WA 98104 |
| Contact | Xiaoxiao Liu |
| Correspondent | Kelliann Payne Hogan Lovells US LLP 1735 Market Street, Floor 23 Philladelphia, PA 19103 |
| Product Code | PJA |
| CFR Regulation Number | 870.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-19 |
| Decision Date | 2022-04-01 |