510(k) K163597
K163597 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "VacLok AT Vacuum Syringe". The FDA issued a decision of Substantially Equivalent on July 27, 2017. The device falls under product code PUR (Vacuum Syringe), a Class II device regulated under 21 CFR 880.5860. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2017
- Date Received
- December 21, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vacuum Syringe
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
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.