DXT — Injector And Syringe, Angiographic Class II
FDA product code DXT covers "Injector And Syringe, Angiographic", a Class II medical device regulated under 21 CFR 870.1650. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXT
- Device Class
- Class II
- Regulation Number
- 870.1650
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252652 | fortis biosolutions company limited | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable S | May 14, 2026 |
| K252638 | acist medical systems | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-U | May 13, 2026 |
| K252653 | acist medical systems | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Modu | May 13, 2026 |
| K253048 | shenzhen maiwei biotech co | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfe | April 16, 2026 |
| K251788 | zhuhai dr medical instruments co | Extension tube | March 5, 2026 |
| K252891 | bayer medical care | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD | February 13, 2026 |
| K244038 | shandong int medical instruments co | High Pressure Tubing | September 5, 2025 |
| K242143 | shandong int medical instruments co | Angiography Injector | December 23, 2024 |
| K242212 | nemoto kyorindo co | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | August 27, 2024 |
| K241109 | shenzhen boon medical supply co | Single-use Sterile High-pressure Angiographic Syringes and Accessories | August 22, 2024 |
| K230668 | precision medical plastics | Disposable High-pressure Extension Lines | June 14, 2024 |
| K232388 | ningbo dizegens medical science co | High Pressure Tubing | November 21, 2023 |
| K211564 | shenzhen boon medical supply co | Sterile High-pressure Angiographic Syringes for Single-use | October 19, 2021 |
| K203004 | acist medical systems | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | December 17, 2020 |
| K201395 | youwo (guangzhou) medical device co | Sterile High-pressure Angiographic Syringes for single-use | October 28, 2020 |
| K192657 | shenzhen boon medical supply co | Sterile High-pressure Angiographic Syringes for Single-use | August 7, 2020 |
| K192370 | bayer medical care | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | December 13, 2019 |
| K193028 | bayer medical care | MEDRAD Mark 7 Arterion Injection System | December 5, 2019 |
| K190102 | osprey medical | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, Dy | October 17, 2019 |
| K191060 | acist medical systems | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT20 | July 18, 2019 |