Alternate Encapsulating Resin System for MCA Hemodialyzers

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K962309 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System

  Class II

  FDA 510(k) K964922 Active Cleared 21 May 1997

• Drake Willock System & Altra Touch 1000 Dialysis Delivery System

  Class II

  FDA 510(k) K970446 Active Cleared 2 Jun 1997

• Altra Nova 200 Hemodailyzer

  Class II

  FDA 510(k) K926379 Active Cleared 13 Feb 1995

• Altra Flux(Tm) 170 Hemodialyzer

  Class II

  FDA 510(k) K945542 Active Cleared 23 May 1995

• Altres(R) 140 Hemodialyzer

  Class II

  FDA 510(k) K945596 Active Cleared 8 Mar 1995

• Altratouch 1000 Hemodialysis Delivery System

  Class II

  FDA 510(k) K954987 Active Cleared 8 Aug 1996

See all devices from Althin Medical AB an Affiliate of Baxter Intl →

• What is the Alternate Encapsulating Resin System for MCA Hemodialyzers used for?

  This device is a capillary, hollow fiber dialyzer designed specifically for hemodialysis. It removes waste products and excess fluids from the bloodstream during treatment. The alternate encapsulating resin system improves filtration efficiency and ensures better toxin clearance, which is critical for patient safety during dialysis sessions.

• Is the Alternate Encapsulating Resin System reusable or single-use?

  The Alternate Encapsulating Resin System is intended for single-use only. This design ensures sterility and reduces the risk of contamination or cross-infection between patients, which is essential in clinical hemodialysis settings.

• How is this device supplied and where is it used?

  The device is supplied as a single-use component and is intended for integration with MCA hemodialyzers. It is designed to be used within hemodialysis machines in clinical environments, where it facilitates blood purification during dialysis treatments.

• What regulatory clearance does this device have?

  This device holds FDA 510(k) clearance under the classification of a Class II medical device, with the clearance type designated as Traditional. The clearance number is K962309, and it is regulated under the product code FJI for dialyzers.

• How should the Alternate Encapsulating Resin System be stored and handled?

  The device follows standard sterile medical device protocols for storage and handling. Since it is single-use, it must be stored in a clean, dry environment to maintain sterility until use. Always adhere to manufacturer guidelines to ensure proper functionality and patient safety.