Product Classification

• 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 Code: NYU
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); 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

Recognized Consensus Standard

• 3-172 AAMI TIR42:2021
  Evaluation of Particulates Associated with Vascular Medical Devices

Guidance Document

• Implanted Blood Access Devices for Hemodialysis - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible