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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter 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 CodeOFC
Regulation Number 870.1340
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 4 4
2022 4 4
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Use of Device Problem 4 4
Material Fragmentation 4 4
Break 3 3
Fracture 2 2
Material Frayed 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 6 6
Thrombosis/Thrombus 6 6
Pseudoaneurysm 3 3
Thromboembolism 2 2
Vessel Or Plaque, Device Embedded In 2 2
Hematoma 2 2
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 2 2
Vascular Dissection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Ischemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Prytime Medical Devices, Inc. II Feb-05-2021
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