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U.S. Department of Health and Human Services

Product Classification

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Device catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeLJS
Premarket Review Office of 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
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Documents
Third Party Review Not Third Party Eligible
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