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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device port introducer kit
Regulation Description Subcutaneous, implanted, intravascular infusion port and 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 CodeOKE
Regulation Number 880.5965
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Detachment Of Device Component 1 1
Fluid Leak 1 1
Tear, Rip or Hole in Device Packaging 1 1
Chemical Spillage 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Chemical Exposure 1 1

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