High Pressure Connecting Sets
FDA 510(k) K890208 · E-Z-Em, Inc.
510(k) numberK890208
Submission
- Device name
- High Pressure Connecting Sets
- Applicant
- E-Z-Em, Inc.
Marlboro, NJ, US - Received
- January 17, 1989
- Decision date
- May 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
Questions and answers
When was High Pressure Connecting Sets cleared by the FDA?
High Pressure Connecting Sets (K890208) received a 510(k) decision of Substantially Equivalent on May 19, 1989, 122 days after the submission was received.
What is the product code of K890208?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.