Angioject
FDA 510(k) K860842 · Target Therapeutics
510(k) numberK860842
Submission
- Device name
- Angioject
- Applicant
- Target Therapeutics
Los Angeles, CA, US - Received
- March 4, 1986
- Decision date
- April 23, 1986
- 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 |
|---|---|---|
| K965071 | Detachable Slicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964488 | Detachable Silicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964210 | Retriever IIDQO · Traditional | 10/31/1997SE |
| K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…DQX · Traditional | 07/14/1997SE |
| K965189 | SpinnakerKRA · Traditional | 03/24/1997SE |
| K964112 | Berenstein CoilKRD · Traditional | 02/26/1997SE |
| K963307 | GDC Patient Return Electtrode Model 45021HCG · Traditional | 12/17/1996SE |
| K962503 | Guglielmi Detachable CoilHCG · Traditional | 09/20/1996SE |
| K961923 | Berenstein CoilHCG · Traditional | 08/15/1996SE |
| K960705 | Guglielmi Detachable CoilHCG · Traditional | 05/21/1996SE |
Questions and answers
When was Angioject cleared by the FDA?
Angioject (K860842) received a 510(k) decision of Substantially Equivalent on April 23, 1986, 50 days after the submission was received.
What is the product code of K860842?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.