QTI · Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | QTI |
|---|---|
| Device Name | Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Becton, Dickinson and Company | Jul 16, 2022 | SESE |
Top Applicants
- Becton, Dickinson and Company — 1 clearance
