Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML
FDA 510(k) K113198 · Navilyst Medical, Inc.
510(k) numberK113198
Submission
- Device name
- Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML
- Applicant
- Navilyst Medical, Inc.
Marlborough, MA, US - Received
- October 31, 2011
- Decision date
- November 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K163452 | PICC Maximal Barrier Nursing KitLJS · Special | 02/03/2017SESK |
| K161866 | BioFlo Midline CatheterFOZ · Traditional | 09/08/2016SE |
| K151239 | Nmi Dual Port IILJT · Traditional | 06/06/2016SE |
| K153228 | NMI Port, NMI Port IILJT · Special | 12/04/2015SE |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS · Special | 09/24/2015SE |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…FGE · Traditional | 09/24/2015SE |
| K150407 | BioFlo Midline CatheterFOZ · Abbreviated | 05/15/2015SE |
| K150527 | Xcela Power Injectable PICCLJS · Special | 03/31/2015SE |
| K150448 | NMI PICC III and NMI PICC IVLJS · Special | 03/19/2015SE |
| K142616 | PICC Maximal Barrier Nursing KitLJS · Special | 10/14/2014SE |
Questions and answers
When was Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML cleared by the FDA?
Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML (K113198) received a 510(k) decision of Substantially Equivalent on November 28, 2011, 28 days after the submission was received.
What is the product code of K113198?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.