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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
Definition To measure pressure within the cardiovascular system.
Product CodeOBI
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2021 1 1
2022 11 11
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 8 8
Break 3 3
Insufficient Information 2 2
Device Damaged by Another Device 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Respiratory Insufficiency 8 8
No Clinical Signs, Symptoms or Conditions 4 4
Vascular Dissection 1 1
Embolism/Embolus 1 1
No Known Impact Or Consequence To Patient 1 1

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