Hemasite Vascular Access Shunt

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K811384 ↗

FDA Product Code

FIQ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Renalloy Hemasite Vascular Access Shunt

  Class II

  FDA 510(k) K833622 Active Cleared 29 Nov 1983

• Primus Hollow Fiber Dialyzer (Models 1000, 1000S, 1350, 1350S, 2000, 2000S)

  Class II

  FDA 510(k) K970648 Active Cleared 5 Jan 1998

• Hemasite Graftless Vascular Acess

  Class II

  FDA 510(k) K812890 Active Cleared 16 Nov 1981

• Actril for Kidney Machine Disinfectant

  Class II

  FDA 510(k) K861730 Active Cleared 9 Jun 1987

• Renaflo II

  Class II

  FDA 510(k) K823546 Active Cleared 16 Dec 1982

• Renal Systems Hemodialysis Concentrate

  Class II

  FDA 510(k) K792213 Active Cleared 4 Jan 1980

See all devices from Renal Systems, Inc. →