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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, hemodialysis, non-implanted, ultrafiltration, for peripheral use
Definition Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Product CodeNQJ
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
NUWELLIS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Dull, Blunt 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dyspnea 2 2
Hemolysis 2 2
Weight Changes 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Injury 1 1

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