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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insufflator, endoscopic vessel harvesting
Regulation Description Laparoscopic insufflator.
Definition To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Product CodeOSV
Regulation Number 884.1730
Device Class 2

Device Problems
Bent 1
Mechanical issue 1
Device remains activated 1
Environmental Particulates 1
Total Device Problems 4

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