NGT
- Product code
- NGT
- Device name
- Saline, Vascular Access Flush
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5200
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 40
FDA classification definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250884 | 2025-12-02 | Becton, Dickinson and Company | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush | |
| K233623 | 2024-02-27 | Medxl, Inc. | Praxiject SP 0.9% NaCl | |
| K231724 | 2023-11-09 | Spm Medicare Pvt. , Ltd. | Flush Syringe (Prefilled 0.9% normal saline solution | |
| K231363 | 2023-09-27 | Hantech Medical Device Co., Ltd. | Hantech Pre-filled 0.9% Normal Saline Flush Syringes |
Official FDA classification page: NGT
Classification and pathway per current FDA publications. Data from openFDA (CC0).