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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventricular bypass (assist) device
Regulation Description Ventricular bypass (assist) device.
Definition A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.
Product CodeOKR
Regulation Number 870.3545
Device Class 3

MDR Year MDR Reports MDR Events
2024 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Electrolyte Imbalance 1 1

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