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510(k) K233069

Removal System Large Bore 60 cc Syringe by Inari Medical, Inc. — Product Code PUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2024
Date Received
September 26, 2023
Clearance Type
Traditional
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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  • K233815 — ClotTriever Sheath (December 18, 2023)
  • K233646 — Intri24 Introducer Sheath (52-101) (December 12, 2023)
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Other clearances for product code PUR

  • K163597 — VacLok AT Vacuum Syringe (July 27, 2017)