DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
FDA 510(k) K190102 · Osprey Medical, Inc.
510(k) numberK190102
Submission
- Device name
- DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
- Applicant
- Osprey Medical, Inc.
Minnetonka, MN, US - Received
- January 22, 2019
- Decision date
- October 17, 2019
- 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 |
|---|---|---|
| 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 |
| K151746 | Dyevert Contrast Modulation SystemDXT · Traditional | 10/09/2015SE |
| K152218 | AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…DXT · Traditional | 09/21/2015SE |
Questions and answers
When was DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System cleared by the FDA?
DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System (K190102) received a 510(k) decision of Substantially Equivalent on October 17, 2019, 268 days after the submission was received.
What is the product code of K190102?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.