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U.S. Department of Health and Human Services

Product Classification

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Device tunneled catheter remover
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.
Physical State The device is made of a rigid or semirigid material and is designed to be able to snap over the catheter body. The deivce may have a hinge or handle to assist in holding the device and manipulating the removal function during operation.
Technical Method The device is designed to snap over a catheter body and to be guided over the cather through the insertion site and into the subcutaneous tissue where the catheter tissue cuff is adhering to the tissue. The user of the catheter removal device, with a gentle twisting and back and forth motion of the device, will manually seperate the catheter cuff from the tissue and be able to fully remove the catheter from the body.
Target Area Tunneled Catheters with tissue ingrowth cuffs.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeODY
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible