K230006 is an FDA 510(k) clearance for the Ankyras. This device is classified as a Software For Visualization Of Vascular Anatomy And Intravascular Devices (Class II - Special Controls, product code PZO).
Submitted by Mentice Spain S.L. (Barcelona, ES). The FDA issued a Cleared decision on December 28, 2023, 359 days after receiving the submission on January 3, 2023.
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 | K230006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2023 |
| Decision Date | December 28, 2023 |
| Days to Decision | 359 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. |