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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device covered stent vascular connector, hemodialysis access circuit
Definition The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site.
Product CodeSEQ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 0 3 0

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Thrombosis/Thrombus 1 1

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