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510(k) K163597

VacLok AT Vacuum Syringe by Merit Medical Systems, Inc. — Product Code PUR

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.

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