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U.S. Department of Health and Human Services

Product Classification

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Device port & catheter, implanted, subcutaneous, intravascular
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeLJT
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 880.5965
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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