Dyevert Contrast Modulation System
FDA 510(k) K151746 · Osprey Medical, Inc.
510(k) numberK151746
Submission
- Device name
- Dyevert Contrast Modulation System
- Applicant
- Osprey Medical, Inc.
Minnetonka, MN, US - Received
- June 29, 2015
- Decision date
- October 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXT – Injector And Syringe, Angiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code DXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/27/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
More from Shenzhen Boon Medical Supply Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K190102 | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert…DXT · Traditional | 10/17/2019SE |
| K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System…DXT · Special | 12/20/2018SE |
| K181936 | DyeVert PLUS EZ Contrast Reduction SystemDXT · Special | 10/25/2018SE |
| K171698 | Smart SyringeDXT · Special | 07/07/2017SE |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemDXT · Special | 05/26/2017SE |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemDXT · Traditional | 03/08/2017SE |
| K161505 | DyeVert NG Contrast Modulation SystemDXT · Special | 08/03/2016SE |
| K153141 | DyeVert Contrast Modulation SystemDXT · Traditional | 02/04/2016SE |
| K151300 | AVERT Contrast Modulation SystemDXT · Traditional | 10/15/2015SE |
| K152218 | AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…DXT · Traditional | 09/21/2015SE |
Questions and answers
When was Dyevert Contrast Modulation System cleared by the FDA?
Dyevert Contrast Modulation System (K151746) received a 510(k) decision of Substantially Equivalent on October 9, 2015, 102 days after the submission was received.
What is the product code of K151746?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.