PUR
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Vacuum Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- FDA 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 infected fluid.
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| Record | Firm | Date |
|---|---|---|
| Removal System Large Bore 60 cc Syringe (K233069) | Inari Medical, Inc. | 2024-03-26 |
| VacLok AT Vacuum Syringe (K163597) | Merit Medical Systems, Inc. | 2017-07-27 |
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Every clearance here is in the API, with alerts when new ones post.