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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
Regulation Description Catheter introducer.
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 5 5
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Physical Resistance/Sticking 4 4
Material Separation 4 4
Defective Device 3 3
Material Integrity Problem 3 3
Product Quality Problem 3 3
Material Frayed 2 2
Fracture 2 2
Defective Component 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Retraction Problem 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 2 2
Pain 2 2
Hemorrhage/Bleeding 2 2
Stroke/CVA 1 1
Occlusion 1 1
Vascular Dissection 1 1
Thrombosis/Thrombus 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Unspecified Vascular Problem 1 1
Liver Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Galt Medical Corporation II May-07-2025
2 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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