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U.S. Department of Health and Human Services

Product Classification
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Device midline catheter
Regulation Description Intravascular catheter.
Definition The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Physical State Consists of a thin, flexible plastic tube that may have a guide wire inside the catheter to add stiffness to facilitate insertion
Technical Method The catheter is inserted into the peripheral vascular system for infusion of fluids and medications.
Target Area The catheter is inserted in the peripheral vascular system (basilic, cephalic, or brachial veins) usually above the antecubital fossa and the tip terminates at or near the axillary area.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePND
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 880.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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