High-Pressure Connector Tube
FDA 510(k) K904212 · Mallinckrodt Medical
510(k) numberK904212
Submission
- Device name
- High-Pressure Connector Tube
- Applicant
- Mallinckrodt Medical
St Louis, MO, US - Received
- September 12, 1990
- Decision date
- December 3, 1990
- 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 |
|---|---|---|
| K082520 | Sealguard Evac Endotracheal and Endotracheal TubesBTR · Special | 10/02/2008SE |
| K051416 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaJOH · Special | 06/16/2005SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | 12/29/1997SE |
| K971267 | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…JOH · Traditional | 09/25/1997SE |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…JOH · Traditional | 06/26/1997SE |
| K955721 | Cuffed Oropharyngeal Airway (Copa)CAE · Traditional | 03/28/1997SE |
| K965132 | Hi-Lo Evac and Evac II Endotracheal TubesBTR · Traditional | 03/20/1997SE |
| K962045 | Anesthesia Breathing Circuit/Anesthesia Breathing KitCAH · Traditional | 11/26/1996SE |
| K962173 | Shikey Tracheostomy Tubes and AccessoriesJOH · Traditional | 10/04/1996SE |
| K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedJOH · Traditional | 03/13/1996SE |
Questions and answers
When was High-Pressure Connector Tube cleared by the FDA?
High-Pressure Connector Tube (K904212) received a 510(k) decision of Substantially Equivalent on December 3, 1990, 82 days after the submission was received.
What is the product code of K904212?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.