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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted subcutaneous securement catheter
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.
Product CodeOKC
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERRAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2026 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Extravasation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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