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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous 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 CodeOFL
Regulation Number 870.1340
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 6 6
2022 5 5
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Material Separation 4 4
Physical Resistance/Sticking 4 4
Fracture 2 2
Material Frayed 2 2
Difficult to Remove 1 1
Retraction Problem 1 1
Defective Component 1 1
Failure to Advance 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 9 9
No Clinical Signs, Symptoms or Conditions 5 5
Hemorrhage/Bleeding 2 2
Pain 2 2
Stroke/CVA 1 1
Laceration(s) 1 1
Occlusion 1 1
Vascular Dissection 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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