Part 892 Subpart B—Diagnostic Devices
FDA submissions for Part 892 Subpart B—Diagnostic Devices in the Cardiovascular (CV) review panel, including product codes, regulations, and recent device decisions.
Section range: § 892.2050
CFR Part: 892
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | 892.2050 | 2 | 10 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253122 | Sim&Size | Sim&Cure | Dec 23, 2025 |
| K250160 | ANKYRAS | Mentice Spain S.L. | May 6, 2025 |
| K242124 | Sim&Size | Sim&Cure | Dec 14, 2024 |
| K230006 | Ankyras | Mentice Spain S.L. | Dec 28, 2023 |
| K222664 | Sim&Size | Sim&Cure | Jan 27, 2023 |
| K213838 | AneuGuide | ArteryFlow Technology Co., Ltd. | Jun 1, 2022 |
| K212373 | Sim&Size | Sim&Cure | Jan 27, 2022 |
| K202322 | Sim&Size | Sim&Cure | Dec 31, 2020 |
| K190049 | Sim&Size | Sim&Cure | Sep 17, 2019 |
| K171534 | SurgicalPreview | Endo Vantage, LLC | Nov 8, 2017 |
