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U.S. Department of Health and Human Services

Product Classification

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Device catheter, intravascular, therapeutic, short-term less than 30 days
Regulation Description Intravascular catheter.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFOZ
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Documents
Third Party Review
Accredited Persons
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