Renaguard Dialysate Filter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945136 ↗

FDA Product Code

FIP

Device Class

Class II

Regulation

21 CFR Part 876.5665

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Minntech Corp. →

• What is the primary function of the Renaguard Dialysate Filter?

  This device serves as a water purification subsystem specifically designed for use in dialysis applications. Its purpose is to filter dialysate to ensure the water quality meets the standards required for medical treatment.

• Who is the manufacturer of this device?

  The Renaguard Dialysate Filter is manufactured by Minntech Corp., located in Minneapolis, Minnesota.

• What is the regulatory status of the Renaguard Dialysate Filter?

  The device has received FDA 510(k) clearance under the K945136 submission. It is categorized under the gastroenterology and urology medical specialty and is classified as a water purification subsystem.