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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tracheobronchial suction catheter kit
Regulation Description Tracheobronchial suction catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOFR
Regulation Number 868.6810
Device Class 1

Device Problems
Valve(s), sticking 1
Total Device Problems 1