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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter guide wire kit
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeOFB
Regulation Number 870.1330
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Too Rigid or Stiff 4 4
Device-Device Incompatibility 1 1
Separation Problem 1 1
Use of Device Problem 1 1
Human-Device Interface Problem 1 1
Difficult to Remove 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Phlebitis 4 4
No Known Impact Or Consequence To Patient 2 2

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