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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flowmeter, blood, cardiovascular
Regulation Description Cardiovascular blood flowmeter.
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
ELFI-TECH , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOSONICS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 1 1
2023 2 2
2024 4 4
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 5 5
Output Problem 3 3
Structural Problem 2 2
Fitting Problem 1 1
Break 1 1
Device Alarm System 1 1
Defective Device 1 1
Failure to Align 1 1
Material Twisted/Bent 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jul-20-2023
2 Flosonics Medical (R/A 1929803 ONTARIO CORP.) III Sep-04-2025
3 Medistim Asa II Oct-29-2025
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