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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemodialysis catheter luer end cap
Definition For use in hemodialysis catheters to reduce hub infection.
Product CodePEH
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
PURSUIT VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
PURSUIT VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 7 7
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Misassembled During Installation 5 5
Detachment of Device or Device Component 5 5
Premature Separation 4 4
Misassembly by Users 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Installation-Related Problem 2 2
Misassembled 1 1
Separation Problem 1 1
Difficult to Insert 1 1
Use of Device Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Transonic Systems Inc II May-09-2018
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