Cleared Abbreviated

VacLok AT Vacuum Syringe

K163597 · Merit Medical Systems, Inc. · General Hospital
Jul 2017
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K163597 is an FDA 510(k) clearance for the VacLok AT Vacuum Syringe, 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 review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K163597 FDA.gov
FDA Decision Cleared 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

Device Classification

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.