High Pressure Flex. Connecting Tubing
FDA 510(k) K841092 · Tronomed, Inc.
510(k) numberK841092
Submission
- Device name
- High Pressure Flex. Connecting Tubing
- Applicant
- Tronomed, Inc.
Walker, MI, US - Received
- March 13, 1984
- Decision date
- July 24, 1985
- 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 |
|---|---|---|
| K952659 | Tronomate Patient Cable & Leadwire SystemDSA · Traditional | 01/11/1996SE |
| K853303 | Lifelinc LeadwireBZQ · Traditional | 09/18/1985SE |
| K853452 | Life Linc Patient CableBZQ · Traditional | 09/10/1985SE |
| K792128 | Sterile Extension Tubes Indiv. Pkg.FMG · Traditional | 01/16/1980SE |
| K792127 | Plas. Stck. W/Extension Tube/SterileFMG · Traditional | 01/16/1980SE |
| K792126 | 3&4 Way Plastic Sterile Stpcks. Pkg.FMG · Traditional | 01/16/1980SE |
| K792125 | 3&4 Way Plastic Stopcocks, NonsterileFMG · Traditional | 01/16/1980SE |
| K792124 | Tandem Assembled 3&4 Way StopcocksFMG · Traditional | 01/16/1980SE |
| K771645 | Electrocardiographic Cablhs & Lead WireDSA · Traditional | 10/18/1977SE |
| K771027 | Electrocardiographic Patient CablesDSA · Traditional | 07/05/1977SE |
Questions and answers
When was High Pressure Flex. Connecting Tubing cleared by the FDA?
High Pressure Flex. Connecting Tubing (K841092) received a 510(k) decision of Substantially Equivalent on July 24, 1985, 498 days after the submission was received.
What is the product code of K841092?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.