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Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

FDA product code NQJ · 4 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5540
Review panel
GU
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2003-12-23 – 2025-08-13

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.

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