Namic Angiographic Syringe
FDA 510(k) K873955 · North American Instrument Corp.
510(k) numberK873955
Submission
- Device name
- Namic Angiographic Syringe
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- September 28, 1987
- Decision date
- February 5, 1988
- 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 |
|---|---|---|
| K960801 | Selector Angiographic Catheter (Various Models)DQO · Traditional | 03/29/1996SE |
| K955554 | Hemo-ValveDTL · Traditional | 03/04/1996SE |
| K960310 | Epic Introducer SheathDYB · Traditional | 02/07/1996SE |
| K922552 | Morse(R) Angiographic CathetersDQO · Traditional | 03/03/1993SE |
| K915078 | Morse Hemostatic Catheter Introducer SetDYB · Traditional | 06/10/1992SE |
| K905208 | Morse AnesthesiaFPA · Traditional | 01/10/1992SE |
| K912961 | Morse Vascular Introducer SetDYB · Traditional | 09/11/1991SE |
| K910764 | The Perceptor(Tm) Stand Alone TransducerDRS · Traditional | 04/22/1991SE |
| K903493 | Namic Contrast Savings Delivery SystemIZI · Traditional | 03/26/1991SE |
| K904275 | Morse Balloon Inflation DeviceMAV · Traditional | 01/03/1991SE |
Questions and answers
When was Namic Angiographic Syringe cleared by the FDA?
Namic Angiographic Syringe (K873955) received a 510(k) decision of Substantially Equivalent on February 5, 1988, 130 days after the submission was received.
What is the product code of K873955?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.