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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stripper, vein, external
Regulation Description External vein stripper.
Product CodeDWQ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
LEMAITRE VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2023 1 1
2024 4 4
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Body Fluid 4 4
Material Split, Cut or Torn 1 1
Defective Component 1 1
Defective Device 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Loss of Power 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 1 1
No Consequences Or Impact To Patient 1 1

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