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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device endoscopic transhepatic venous access needle
Definition An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.
Product CodeQIJ
Regulation Number 876.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK IRELAND LTD.
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 3 3
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Bleeding 1 1

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