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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device graft, vascular, stainless steel tunneler
Regulation Description Vascular graft prosthesis.
Product CodeMZY
Regulation Number 870.3450
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 2 2
Crack 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Device Markings/Labelling Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Blood Loss/Bleeding 1 1
Perforation 1 1

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