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U.S. Department of Health and Human Services

Product Classification
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Device catheter, hemodialysis, implanted, coated
Regulation Description Blood access device and accessories.
Definition Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Physical State Tube of plastic
Technical Method Circulates blood from the vascular system to a hemodialysis machine. The coatings on the catheter reduce infection or thrombosis by local affects on the blood
Target Area Central venous system
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNYU
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
Guidance Document
Third Party Review Not Third Party Eligible
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