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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 Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5970
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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