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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiovascular delivery catheter system positioning and stabilization device
Definition A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.
Product CodeQWA
Regulation Number 870.3955
Device Class 1

MDR Year MDR Reports MDR Events
2023 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Tissue Injury 1 1

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