Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5540
Review panel
GU
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.