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U.S. Department of Health and Human Services

Product Classification

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Device percutaneous, implanted, long-term intravascular catheter accessory for catheter position
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Physical State stainless steel stylet
Technical Method device is placed inside a central venous catheter
Target Area blood vessels
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOMF
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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