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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Central venous catheter with subcutaneous securement system.
Technical Method Central venous catheter with subcutaneous securement system.
Target Area vascular system, subcutaneous tissue.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOKC
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5970
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible