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U.S. Department of Health and Human Services

Product Classification
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Device fully subcutaneous implanted hemodialysis catheter
Regulation Description Blood access device and accessories.
Definition Provides access to the blood for hemodialysis or other chronic uses.
Physical State fully subcutaneous implanted hemodialysis catheter
Technical Method Provides fully subcutaneous access to the blood for hemodialysis or other cronic uses.
Target Area internal jugular or femoral veins via the skin and subcutanous tissue
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePKI
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5540
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? Yes
Third Party Review Not Third Party Eligible
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