The following data is part of a premarket notification filed by Arteryflow Technology Co., Ltd. with the FDA for Aneuguide.
| Device ID | K213838 |
| 510k Number | K213838 |
| Device Name: | AneuGuide |
| Classification | Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Applicant | ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District, Hangzhou, CN 310051 |
| Contact | Jianping Xiang |
| Correspondent | Jianping Xiang ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District, Hangzhou City, CN 310051 |
| Product Code | PZO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-06-01 |