NGT · Saline, Vascular Access Flush
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | NGT |
|---|---|
| Device Name | Saline, Vascular Access Flush |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson and Company | Dec 2, 2025 | SESE |
| K233623 | Praxiject SP 0.9% NaCl | Medxl, Inc. | Feb 27, 2024 | SESE |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt. , Ltd. | Nov 9, 2023 | SESE |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | Hantech Medical Device Co., Ltd. | Sep 27, 2023 | SESE |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | Anhui Tiankang Medical Technology Co., Ltd. | Aug 12, 2023 | SESE |
| K223584 | Pre-Filled Normal Saline Flush Syringe | Anhui Tianyang Pharmaceutical Co., Ltd. | Aug 12, 2023 | SESE |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe | Becton, Dickinson and Company | Jul 21, 2023 | SESE |
| K231754 | Praxiject 0.9% NaCl | Medxl, Inc. | Jul 13, 2023 | SESE |
| K214080 | Pentaflush | Pentaferte Italia S.R.L. | Jul 20, 2022 | SESE |
| K220060 | Pre-filled Syringe with Saline | Jiangsu Caina Medical Co.,Ltd | Jun 10, 2022 | SESE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | Mar 22, 2022 | SESE |
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch | Nurse Assist, LLC | Aug 11, 2020 | SESE |
| K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | Feb 13, 2020 | SESE |
| K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | Medline Industries, Inc. | Sep 15, 2019 | SESE |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | Jul 12, 2019 | SESE |
| K173348 | 0.9% Sodium Chloride Injection, USP | Medline Industries, Inc. | Jun 21, 2018 | SESE |
| K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | Dec 21, 2017 | SESE |
| K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | Becton, Dickinson and Company | Feb 2, 2017 | SESE |
| K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | Becton, Dickinson and Company | Apr 4, 2016 | SESE |
| K150143 | Normal Saline Flush | Nurse Assist, Inc. | Aug 31, 2015 | SESE |
Top Applicants
- Becton, Dickinson and Company — 5 clearances
- Am USA — 4 clearances
- Medefil, Inc. — 4 clearances
- Medxl, Inc. — 4 clearances
- Amsino International, Inc. — 2 clearances
