Software For Visualization Of Vascular Anatomy And Intravascular Devices
Regulation 892.2050
1510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Sim&Cure | 6 | 0 |
| Mentice Spain S.L. | 2 | 0 |
| ArteryFlow Technology Co., Ltd. | 1 | 0 |
| Endo Vantage, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2025 | K253122 | Sim&Size Sim&Cure, FR | PZO |
| May 6, 2025 | K250160 | ANKYRAS Mentice Spain S.L., ES | PZO |
| Dec 14, 2024 | K242124 | Sim&Size Sim&Cure, FR | PZO |
| Dec 28, 2023 | K230006 | Ankyras Mentice Spain S.L., ES | PZO |
| Jan 27, 2023 | K222664 | Sim&Size Sim&Cure, FR | PZO |
| Jun 1, 2022 | K213838 | AneuGuide ArteryFlow Technology Co., Ltd., CN | PZO |
| Jan 27, 2022 | K212373 | Sim&Size Sim&Cure, FR | PZO |
| Dec 31, 2020 | K202322 | Sim&Size Sim&Cure, FR | PZO |
| Sep 17, 2019 | K190049 | Sim&Size Sim&Cure, FR | PZO |
| Nov 8, 2017 | K171534 | SurgicalPreview Endo Vantage, LLC | PZO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.