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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urethral insert with pump for bladder drainage
Definition The device is intended to empty urine from the bladder under patient control.
Product CodePIH
Regulation Number 876.5140
Device Class 2


Premarket Reviews
ManufacturerDecision
VESIFLO, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1 1
Urinary Tract Infection 1 1

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