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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cardiac catheterization kit
Regulation Description Diagnostic intravascular 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 CodeOES
Regulation Number 870.1200
Device Class 2

Device Problems
Transducer failure 2
Detachment of device or device component 2
Unknown (for use when the device problem is not known) 1
Air leak 1
Crack 1
Leak 1
Loose or intermittent connection 1
Material separation 1
Total Device Problems 10