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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
2023 1 1
2024 4 4
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Body Fluid 7 7
Material Split, Cut or Torn 2 2
Connection Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10

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