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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, pressure monitoring, cardiac
Regulation Description Diagnostic intravascular catheter.
Definition To measure pressure within the cardiovascular system.
Product CodeOBI
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 2
2022 11 11
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 8 8
Break 4 5
Insufficient Information 1 1
Device Contamination with Chemical or Other Material 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Respiratory Insufficiency 8 8
No Clinical Signs, Symptoms or Conditions 5 6
Embolism/Embolus 1 1

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