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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vacuum syringe
Regulation Description Piston syringe.
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.
Product CodePUR
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

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