K250160 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 May 6, 2025, 105 days after receiving the submission on January 21, 2025.
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 | K250160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | May 06, 2025 |
| Days to Decision | 105 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. |