K163597 is an FDA 510(k) clearance for the VacLok AT Vacuum Syringe. This device is classified as a Vacuum Syringe (Class II - Special Controls, product code PUR).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 27, 2017, 218 days after receiving the submission on December 21, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. 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..
| 510(k) Number | K163597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2016 |
| Decision Date | July 27, 2017 |
| Days to Decision | 218 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PUR — Vacuum Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| 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. |