NGT — Saline, Vascular Access Flush Class II
FDA product code NGT covers "Saline, Vascular Access Flush", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NGT
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250884 | becton, dickinson and | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | December 2, 2025 |
| K233623 | medxl | Praxiject SP 0.9% NaCl | February 27, 2024 |
| K231724 | spm medicare pvt. | Flush Syringe (Prefilled 0.9% normal saline solution) | November 9, 2023 |
| K231363 | hantech medical device co | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, | September 27, 2023 |
| K223584 | anhui tianyang pharmaceutical co | Pre-Filled Normal Saline Flush Syringe | August 12, 2023 |
| K230756 | anhui tiankang medical technology co | TK Pre-Filled Normal Saline Flush Syringe | August 12, 2023 |
| K231161 | becton, dickinson and | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe | July 21, 2023 |
| K231754 | medxl | Praxiject 0.9% NaCl | July 13, 2023 |
| K214080 | pentaferte italia | Pentaflush | July 20, 2022 |
| K213522 | amsino international | AMSafe Pre-Filled Normal Saline Flush Syringe | March 22, 2022 |
| K201286 | nurse assist | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0 | August 11, 2020 |
| K192414 | medxl | Praxiject 0.9% NaCl | February 13, 2020 |
| K191378 | medline industries | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | September 15, 2019 |
| K183473 | amsino international | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | July 12, 2019 |
| K173348 | medline industries | 0.9% Sodium Chloride Injection, USP | June 21, 2018 |
| K171109 | medxl | Praxiject 0.9% NaCl | December 21, 2017 |
| K161552 | becton, dickinson and | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | February 2, 2017 |
| K153481 | becton, dickinson and | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | April 4, 2016 |
| K150143 | nurse assist | Normal Saline Flush | August 31, 2015 |
| K142620 | excelsior medical corporation | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chlori | December 12, 2014 |