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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flushing solution for short term storage of veins at room temperature during coronary artery bypass graft surgeries
Definition A flushing and storage solution for vascular autografts is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure.
Product CodeQEJ
Regulation Number 876.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MARIZYME
  SUBSTANTIALLY EQUIVALENT 1
MARIZYME, INC.
  GRANTED 1

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