Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Physical Resistance/Sticking 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

-
-