Definition: The Vacuum Syringe Is Intended To Be Used As A General Purpose Syringe For Injection And Withdrawal Of Fluids And Can Be Locked In Place To Create A Vacuum For Removal Of Fluid And/or Tissue From The Body In The Form Of Thrombus, Abscess Fluid, And I
| Device Type ID | 2759 |
| Device Name | Vacuum Syringe |
| Physical State | The Vacuum Syringe Consists Of A Barrel, Plunger, Piston Seal And A Locking Mechanism. |
| Technical Method | A Vacuum Syringe May Be Used In Instances Where Fluid And/or Tissue Needs To Be Removed From The Body In The Form Of Thrombus, Abscess Fluid, And Infected Fluid (e.g. Urine, Bile, Etc,). Thrombus And Other Fluid Can Be Thick, Which Makes It Difficult |
| Target Area | Human Fluid |
| Regulation Description | Piston Syringe. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2759 |
| Device | Vacuum Syringe |
| Product Code | PUR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Piston Syringe. |
| CFR Regulation Number | 880.5860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |