MEDRAD Mark 7 Arterion Injection System
FDA 510(k) K193028 · Bayer Medical Care, Inc.
510(k) numberK193028
Submission
- Device name
- MEDRAD Mark 7 Arterion Injection System
- Applicant
- Bayer Medical Care, Inc.
Indianaola, PA, US - Received
- October 30, 2019
- Decision date
- December 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer SpikePQH · Traditional | 06/12/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | 02/13/2026SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | 09/04/2025SE |
| K200280 | MEDRAD Imaging Bulk Package Transfer SpikePQH · Traditional | 07/30/2020SE |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationDXT · Traditional | 12/13/2019SE |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT · Special | 11/01/2018SE |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Special | 11/01/2018SE |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Traditional | 08/17/2018SE |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe KitDXT · Traditional | 08/14/2015SE |
Questions and answers
When was MEDRAD Mark 7 Arterion Injection System cleared by the FDA?
MEDRAD Mark 7 Arterion Injection System (K193028) received a 510(k) decision of Substantially Equivalent on December 5, 2019, 36 days after the submission was received.
What is the product code of K193028?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.