Viaspan Belzer Uw

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Labeling Change - Viaspan(Tm) (Belzer Uw)

510(k) Number

K900492 ↗

FDA Product Code

KDL

Device Class

Class II

Regulation

21 CFR Part 876.5880

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K885259 Active Cleared 17 Feb 1989

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  FDA 510(k) K884002 Active Cleared 31 Oct 1988

• Aca Thyroxine (T4 E) Method

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• Dupont Aca Vancomycin (Vanc) Method

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  FDA 510(k) K945125 Active Cleared 10 Mar 1995

• Modular Daylight Cassette for Video Imaging

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  FDA 510(k) K953477 Active Cleared 7 Oct 1995

• Analyst Theophylline Calibrator

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  FDA 510(k) K884170 Active Cleared 16 Nov 1988

See all devices from The DU Pont Co. →

• What is the Viaspan Belzer UW intended for?

  The Viaspan Belzer UW is a disposable perfusion set specifically designed for kidney applications. It is categorized under the gastroenterology and urology medical specialties for clinical use.

• Is this device intended for single use?

  Yes, the Viaspan Belzer UW is classified as a disposable kidney perfusion set. This means it is designed to be used once and then discarded to maintain clinical safety and performance standards.

• What is the regulatory status of this device?

  The Viaspan Belzer UW is a class 2 medical device that has received FDA 510(k) clearance under K900492. It is regulated under 21 CFR 876.5880, which pertains to kidney perfusion sets.