K213838 is an FDA 510(k) clearance for the AneuGuide. This device is classified as a Software For Visualization Of Vascular Anatomy And Intravascular Devices (Class II - Special Controls, product code PZO).
Submitted by ArteryFlow Technology Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on June 1, 2022, 174 days after receiving the submission on December 9, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.2050. Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning..
| 510(k) Number | K213838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2021 |
| Decision Date | June 01, 2022 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PZO - Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning. |