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U.S. Department of Health and Human Services

Product Classification

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Device catheter introducer
Definition The catheter introducer is intended to provide a path for a catheter to be placed near nerves or into and around wound sites for the delivery local anesthesia.
Physical State The needle is made from stainless steel material with a sharp beveled tip. The proximal end of the needle consist of a female luer made of polystyrene. The sheath tube consist of Soltex with a split -T hub. The sheath tube is scored the length of the tube.
Technical Method The catheter introducer consist of a stainless steel needle with a sharp tip surrounded by a plastic peelable sheath. The needle with Sheath is inserted through the skin to the wound site or nerves for regional anesthesia. Once at the desired location the needle is removed and the catheter is inserted through the plastic sheath. With the catheter in place, the plastic sheath with a Split T handle is removed from the skin leaving the catheter in place.
Target Area nerves
Review Panel Anesthesiology
Product CodePNC
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible