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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiovascular catheter sheath introducer kit
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 CodeOEX
Regulation Number 870.1340
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Difficult to Remove 2 2
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 2 2
Vascular Dissection 2 2
Thrombosis/Thrombus 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hemorrhage/Bleeding 1 1
Extravasation 1 1

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